Lamotrigine 5 mg Dispersible Tablets

1. Name Of The Medicinal Product

Lamotrigine 5 mg Dispersible Tablets

2. Qualitative And Quantitative Composition

Each tablet contains lamotrigine 5 mg

For excipients, see 6.1.

3. Pharmaceutical Form

“Dispersible Tablet”

White or almost white, capsule shape, biconvex, uncoated tablets with “5” marked on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Epilepsy

Adults and adolescents aged 13 years and above

− Adjunctive or monotherapy treatment of partial seizures and generalised seizures, including tonic-clonic seizures.

− Seizures associated with Lennox-Gastaut syndrome. Lamotrigine Dispersible Tablets is given as adjunctive therapy but may be the initial antiepileptic drug (AED) to start with in Lennox-Gastaut syndrome.

Children and adolescents aged 2 to 12 years

− Adjunctive treatment of partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut syndrome.

− Monotherapy of typical absence seizures.

Bipolar disorder

Adults aged 18 years and above

− Prevention of depressive episodes in patients with bipolar I disorder who experience predominantly depressive episodes (see section 5.1).

Lamotrigine Dispersible Tablets is not indicated for the acute treatment of manic or depressive episodes.

4.2 Posology And Method Of Administration

Administration

Lamotrigine Dispersible Tablets may be chewed, dispersed in a small volume of water (at least enough to cover the tablet) or swallowed whole with a little water.

If the calculated dose of lamotrigine (for example for treatment of children with epilepsy or patients with hepatic impairment) does not equate to whole tablets, the dose to be administered is that equal to the lower number of whole tablets.

Restarting therapy

Prescribers should assess the need for escalation to maintenance dose when restarting Lamotrigine Dispersible Tablets in patients who have discontinued Lamotrigine Dispersible Tablets for any reason, since the risk of serious rash is associated with high initial doses and exceeding the recommended dose escalation for lamotrigine (see section 4.4). The greater the interval of time since the previous dose, the more consideration should be given to escalation to the maintenance dose. When the interval since discontinuing lamotrigine exceeds five half-lives (see section 5.2), Lamotrigine Dispersible Tablets should generally be escalated to the maintenance dose according to the appropriate schedule.

It is recommended that Lamotrigine Dispersible Tablets not be restarted in patients who have discontinued due to rash associated with prior treatment with lamotrigine unless the potential benefit clearly outweighs the risk.

Epilepsy

The recommended dose escalation and maintenance doses for adults and adolescents aged 13 years and above (Table 1) and for children and adolescents aged 2 to 12 years (Table 2) are given below. Because of a risk of rash the initial dose and subsequent dose escalation should not be exceeded (see section 4.4).

When concomitant AEDs are withdrawn or other AEDs/medicinal products are added on to treatment regimes containing lamotrigine, consideration should be given to the effect this may have on lamotrigine pharmacokinetics (see section 4.5).

Table 1: Adults and adolescents aged 13 years and above - recommended treatment regimen in epilepsy

Treatment regimen	Weeks 1 + 2	Weeks 3 + 4	Usual maintenance dose
Monotherapy:	25mg/day (once a day)	50mg/day (once a day)	100 - 200mg/day (once a day or two divided doses) To achieve maintenance, doses may be increased by maximum of 50 - 100mg everyone to two weeks until optimal response is achieved 500mg/day has been required by some patients to achieve desired response
Adjunctive therapy WITH valproate (inhibitor of lamotrigine glucuronidation - see section 4.5):
This dosage regimen should be used with valproate regardless of any concomitant medicinal products	12.5mg/day (given as 25mg on alternate days)	25mg/day (once a day)	100 - 200mg/day (once a day or two divided doses) To achieve maintenance, doses may be increased by maximum of 25 - 50mg every one to two weeks until optimal response is achieved
Adjunctive therapy WITHOUT valproate and WITH inducers of lamotrigine glucuronidation (see section 4.5):
This dosage regimen should be used without valproate but with: phenytoin carbamazepine phenobarbital primidone rifampicin lopinavir/ritonavir	50mg/day (once a day)	100mg/day (two divided doses)	200 - 400mg/day (two divided doses) To achieve maintenance, doses may be increased by maximum of 100mg every one to two weeks until optimal response is achieved 700mg/day has been required by some patients to achieve desired response
Adjunctive therapy WITHOUT valproate and WITHOUT inducers of lamotrigine glucuronidation (see section 4.5):
This dosage regimen should be used with other medicinal products that do not significantly inhibit or induce lamotrigine glucuronidation	25mg/day (once a day)	50mg/day (once a day)	100 - 200mg/day (once a day or two divided doses) To achieve maintenance, doses may be increased by maximum of 50 - 100mg every one to two weeks until optimal response is achieved
In patients taking medicinal products where the pharmacokinetic interaction with lamotrigine is currently not known (see section 4.5), the treatment regimen as recommended for lamotrigine with concurrent valproate should be used.

Table 2: Children and adolescents aged 2 to 12 years - recommended treatment regimen in epilepsy (total daily dose in mg/kg body weight/day)

Treatment regimen	Weeks 1 + 2	Weeks 3 + 4	Usual maintenance dose
Monotherapy of typical absence seizures:	0.3mg/kg/day (once a day or two divided doses)	0.6mg/kg/day (once a day or two divided doses)	1 - 10mg/kg/day, although some patients have required higher doses (up to 15mg/kg/day) to achieve desired response (once a day or two divided doses) To achieve maintenance, doses may be increased by maximum of 0.6mg/kg/day every one to two weeks until optimal response is achieved
Adjunctive therapy WITH valproate (inhibitor of lamotrigine glucuronidation - see section 4.5):
This dosage regimen should be used with valproate regardless of any other concomitant medicinal products	0.15mg/kg/day * (once a day)	0.3mg/kg/day (once a day)	1 - 5mg/kg/day (once a day or two divided doses) To achieve maintenance, doses may be increased by maximum of 0.3mg/kg every one to two weeks until optimal response is achieved, with a maximum maintenance dose of 200mg/day
Adjunctive therapy WITHOUT valproate and WITH inducers of lamotrigine glucuronidation (see section 4.5):
This dosage regimen should be used without valproate but with: phenytoin carbamazepine phenobarbital primidone rifampicin lopinavir/ritonavir	0.6mg/kg/day (two divided doses)	1.2mg/kg/day (two divided doses)	5 - 15mg/kg/ day (once a day or two divided doses) To achieve maintenance, doses may be increased by maximum of 1.2mg/kg every one to two weeks until optimal response is achieved, with a maximum maintenance dose of 400mg/day
Adjunctive therapy WITHOUT valproate and WITHOUT inducers of lamotrigine glucuronidation (see section 4.5):
This dosage regimen should be used with other medicinal products that do not significantly inhibit or induce lamotrigine glucuronidation	0.3mg/kg/day (once a day or two divided doses)	0.6mg/kg/day (once a day or two divided doses)	1 - 10mg/kg/day (once a day or two divided doses) To achieve maintenance, doses may be increased by maximum of 0.6mg/kg every one to two weeks until optimal response is achieved, with a maximum of maintenance dose of 200mg/day
In patients taking medicinal products where the pharmacokinetic interaction with lamotrigine is currently not known (see section 4.5), the treatment regimen as recommended for lamotrigine with concurrent valproate should be used.
* If the calculated daily dose in patients taking valproate is 2.5mg or more but less than 5mg, then Lamotrigine 5mg dispersible/chewable tablets may be taken on alternate days for the first two weeks. If the calculated daily dose in patients taking valproate is less than 2.5mg, then Lamotrigine should not be administered.

To ensure a therapeutic dose is maintained the weight of a child must be monitored and the dose reviewed as weight changes occur. It is likely that patients aged two to six years will require a maintenance dose at the higher end of the recommended range.

If epileptic control is achieved with adjunctive treatment, concomitant AEDs may be withdrawn and patients continued on Lamotrigine Dispersible Tablets monotherapy.

It should be noted that with the currently available Lamotrigine 5mg dispersible/chewable tablet strength, it is not possible to accurately initiate lamotrigine therapy using the recommended dosing guidelines in paediatric patients weighing less than 17kg

Children below 2 years

There are limited data on the efficacy and safety of lamotrigine for adjunctive therapy of partial seizures in children aged 1 month to 2 years (see section 4.4). There are no data in children below 1 month of age. Thus Lamotrigine Dispersible Tablets is not recommended for use in children below 2 years of age. If, based on clinical need, a decision to treat is nevertheless taken, see sections 4.4, 5.1 and 5.2.

Bipolar disorder

The recommended dose escalation and maintenance doses for adults of 18 years of age and above are given in the tables below. The transition regimen involves escalating the dose of lamotrigine to a maintenance stabilisation dose over six weeks (Table 3) after which other psychotropic medicinal products and/or AEDs can be withdrawn, if clinically indicated (Table 4). The dose adjustments following addition of other psychotropic medicinal products and/or AEDs are also provided below (Table 5). Because of the risk of rash the initial dose and subsequent dose escalation should not be exceeded (see section 4.4).

Table 3: Adults aged 18 years and above - recommended dose escalation to the maintenance total daily stabilisation dose in treatment of bipolar disorder

Treatment Regimen	Weeks 1 + 2	Weeks 3 + 4	Week 5	Target Stabilisation Dose (Week 6)*
Monotherapy with lamotrigine OR adjunctive therapy WITHOUT valproate and WITHOUT inducers of lamotrigine glucuronidation (see section 4.5):
This dosage regimen should be used with other medicinal products that do not significantly inhibit or induce lamotrigine glucuronidation	25mg/day (once a day)	50mg/day (once a day or two divided doses	100mg/day (once a day or two divided doses)	200mg/day – usual target dose for optimal response (once a day or two divided doses) Doses In the range 100 - 400mg/day used in clinical trials
Adjunctive therapy WITH valproate (inhibitor of lamotrigine glucuronidation - see section 4.5):
This dosage regimen should be used with valproate regardless of any concomitant medicinal products	12.5mg/day (given as 25mg on alternate days)	25mg/day (once a day)	50mg/day (once a day or two divided doses)	100mg/day – usual target dose for optimal response (once a day or two divided doses) Maximum dose of 200mg/day can be used depending on clinical response
Adjunctive therapy WITHOUT valproate and WITH inducers of lamotrigine glucuronidation (see section 4.5):
This dosage regimen should be used without valproate but with: phenytoin carbamazepine phenobarbital primidone rifampicin lopinavir/ritonavir	50mg/day (once a day)	100mg/day (two divided doses)	200mg/day (two divided doses)	300mg/day in week 6, if necessary increasing to usual target dose of 400mg/day in week 7, to achieve optimal response (two divided doses)
In patients taking medicinal products where the pharmacokinetic interaction with lamotrigine is currently not known (see section 4.5), the dose escalation as recommended for lamotrigine with concurrent valproate, should be used.

* The Target stabilisation dose will alter depending on clinical response

Table 4: Adults aged 18 years and above - maintenance stabilsation total daily dosefollowing withdrawal of concomitant medicinal products in treatment of bipolar disorder

Once the target daily maintenance stabilisation dose has been achieved, other medicinal products may be withdrawn as shown below.

Treatment Regimen	Current lamotrigine stabilisation dose (prior to withdrawal)	Week 1 (beginning with withdrawal)	Week 2	Week 3 onwards *
Withdrawal of valproate (inhibitor of lamotrigine glucuronidation - see section 4.5), depending on original dose of lamotrigine:
When valproate is withdrawn, double the stabilisation dose, not exceeding an increase of more than 100 mg/week	100mg/day	200mg/day	Maintain this dose (200mg/day) (two divided doses)
200mg/day	300mg/day	400mg/day	Maintain this dose (400mg/day)
Withdrawal of inducers of lamotrigine glucuronidation (see section 4.5), depending on original dose of lamotrigine:
This dosage regimen should be used when the following are withdrawn: phenytoin carbamazepine phenobarbital primidone rifampicin lopinavir/ritonavir	400mg/day	400mg/day	300mg/day	200mg/day
300mg/day	300mg/day	225mg/day	150mg/day
200mg/day	200mg/day	150mg/day	100mg/day
Withdrawal of medicinal products that do NOT signifcantly inhibit or induce lamotrigine glucuronidation (see section 4.5):
This dosage regimen should be used when other medicinal products that do not significantly inhibit or induce lamotrigine glucuronidation are withdrawn	Maintain target dose achieved in dose escalation (200mg/day; two divided doses) (dose range 100 - 400mg/day)
In patients taking medicinal products where the pharmacokinetic interaction with lamotrigine is currently not known (see section 4.5), the treatment regimen as recommended for lamotrigine with concurrent valproate should be used.

* Dose may be increased to 400mg/day as needed

Table 5: Adults aged 18 years and above - adjustment of lamotrigine daily dosing following the addition of other medicinal products in treatment of bipolar disorder

There is no clinical experience in adjusting the lamotrigine daily dose following the addition of other medicinal products. However, based on interaction studies with other medicinal products, the following recommendations can be made:

Treatment Regimen	Current lamotrigine stabilisation dose (prior to addition)	Week 1 (beginning with addition)	Week 2	Week 3 onwards
Addition of valproate (inhibitor of lamotrigine glucuronidation - see section 4.5), depending on original dose of lamotrigine:
This dosage regimen should be used when valproate is added regardless of any concomitant medicinal products	200mg/day	100mg/day	Maintain this dose (100mg/day)
300mg/day	150mg/day	Maintain this dose (150mg/day)
400mg/day	200mg/day	Maintain this dose (200mg/day)
Addition of inducers of lamotrigine glucuronidation in patients NOT taking valproate (see section 4.5), depending on original dose of lamotrigine:
This dosage regimen should be used when the following are added without valproate: phenytoin carbamazepine phenobarbital primidone rifampicin lopinavir/ritonavir	200mg/day	200mg/day	300mg/day	400mg/day
150mg/day	150mg/day	225mg/day	300mg/day
100mg/day	100mg/day	150mg/day	200mg/day
Addition of medicinal products that do NOT significantly inhibit or induce lamotrigine glucuronidation (see section 4.5):
This dosage regimen should be used when other medicinal products that do not significantly inhibit or induce lamotrigine glucuronidation are added	Maintain target dose achieved in dose escalation (200mg/day; dose range 100-400mg/day)
In patients taking medicinal products where the pharmacokinetic interaction with lamotrigine is currently not known (see section 4.5), the treatment regimen as recommended for lamotrigine with concurrent valproate, should be used.

Discontinuation of Lamotrigine Dispersible Tablets in patients with bipolar disorder

In clinical trials, there was no increase in the incidence, severity or type of adverse reactions following abrupt termination of lamotrigine versus placebo. Therefore, patients may terminate Lamotrigine Dispersible Tablets without a step-wise reduction of dose.

Children and adolescents below 18 years

Lamotrigine Dispersible Tablets is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy (see section 4.4).

General dosing recommendations for Lamotrigine Dispersible Tablets in special patient populations

Women taking hormonal contraceptives

The use of an ethinyloestradiol/levonorgestrel (30µg/150µg) combination increases the clearance of lamotrigine by approximately two-fold, resulting in decreased lamotrigine levels. Following titration, higher maintenance doses of lamotrigine (by as much as two-fold) may be needed to attain a maximal therapeutic response. During the pill-free week, a two-fold increase in lamotrigine levels has been observed. Dose-related adverse events cannot be excluded. Therefore, consideration should be given to using contraception without a pill-free week, as first-line therapy (for example, continuous hormonal contraceptives or non-hormonal methods; see sections 4.4 and 4.5).

Starting hormonal contraceptives in patients already taking maintenance doses of lamotrigine and NOT taking inducers of lamotrigine glucuronidation

The maintenance dose of lamotrigine will in most cases need to be increased by as much as two-fold (see sections 4.4 and 4.5). It is recommended that from the time that the hormonal contraceptive is started, the lamotrigine dose is increased by 50 to 100mg/day every week, according to the individual clinical response. Dose increases should not exceed this rate, unless the clinical response supports larger increases. Measurement of serum lamotrigine concentrations before and after starting hormonal contraceptives may be considered, as confirmation that the baseline concentration of lamotrigine is being maintained. If necessary, the dose should be adapted. In women taking a hormonal contraceptive that includes one week of inactive treatment ("pill-free week"), serum lamotrigine level monitoring should be conducted during week 3 of active treatment, i.e. on days 15 to 21 of the pill cycle. Therefore, consideration should be given to using contraception without a pill-free week, as first-line therapy (for example, continuous hormonal contraceptives or non-hormonal methods; see sections 4.4 and 4.5).

Stopping hormonal contraceptives in patients already taking maintenance doses of lamotrigine and NOT taking inducers oflamotrigine glucuronidation

The maintenance dose of lamotrigine will in most cases need to be decreased by as much as 50% (see sections 4.4 and 4.5). It is recommended to gradually decrease the daily dose of lamotrigine by 50-100mg each week (at a rate not exceeding 25% of the total daily dose per week) over a period of 3 weeks, unless the clinical response indicates otherwise. Measurement of serum lamotrigine concentrations before and after stopping hormonal contraceptives may be considered, as confirmation that the baseline concentration of lamotrigine is being maintained. In women who wish to stop taking a hormonal contraceptive that includes one week of inactive treatment ("pill-free week"), serum lamotrigine level monitoring should be conducted during week 3 of active treatment, i.e. on days 15 to 21 of the pill cycle. Samples for assessment of lamotrigine levels after permanently stopping the contraceptive pill should not be collected during the first week after stopping the pill.

Starting lamotrigine in patients already taking hormonal contraceptives

Dose escalation should follow the normal dose recommendation described in the tables.

Starting and stopping hormonal contraceptives in patients already taking maintenance doses of lamotrigine and TAKING inducers of lamotrigine glucuronidation

Adjustment to the recommended maintenance dose of lamotrigine may not be required.

Elderly(above 65 years)

The pharmacokinetics of lamotrigine in this age group do not differ significantly from a non-elderly population and therefore no dosage adjustment is required.

Renal impairment

Caution should be exercised when administering Lamotrigine Dispersible Tablets to patients with renal failure. For patients with end-stage renal failure, initial doses of lamotrigine should be based on patients' concomitant medicinal products; reduced maintenance doses may be effective for patients with significant renal functional impairment (see sections 4.4 and 5.2).

Hepatic Impairment

Doses should generally be reduced by approximately 50% in patients with moderate hepatic impairment (Child-Pugh grade B) and 75% in patients with severe hepatic impairment (Child-Pugh grade C). Escalation and maintenance doses should be adjusted according to clinical response.

4.3 Contraindications

Hypersensitivity to Lamotrigine Dispersible Tablets or any of the excipients of this product

4.4 Special Warnings And Precautions For Use

Skin rash

There have been reports of adverse skin reactions, which have generally occurred within the first eight weeks after initiation of lamotrigine treatment. The majority of rashes are mild and self-limiting, however serious rashes requiring hospitalisation and discontinuation of lamotrigine have also been reported. These have included potentially life-threatening rashes such as Stevens-Johnson syndrome and toxic epidermal necrolysis (see section 4.8).

In adults enrolled in studies utilizing the current lamotrigine dosing recommendations the incidence of serious skin rashes is approximately 1 in 500 in epilepsy patients.

Approximately half of these cases have been reported as Stevens-Johnson syndrome (1 in 1000). In clinical trials in patients with bipolar disorder, the incidence of serious rash is approximately 1 in 1000.

The risk of serious skin rashes in children is higher than in adults. Available data from a number of studies suggest the incidence of rashes associated with hospitalisation in epileptic children is from 1 in 300 to 1 in 100.

In children, the initial presentation of a rash can be mistaken for an infection, physicians should consider the possibility of a reaction to lamotrigine treatment in children that develop symptoms of rash and fever during the first eight weeks of therapy.

Additionally the overall risk of rash appears to be strongly associated with:

− high initial doses of lamotrigine and exceeding the recommended dose escalation of lamotrigine therapy (see section 4.2)

− concomitant use of valproate (see section 4.2).

Caution is also required when treating patients with a history of allergy or rash to other AEDs as the frequency of non-serious rash after treatment with lamotrigine was approximately three times higher in these patients than in those without such history.

All patients (adults and children) who develop a rash should be promptly evaluated and Lamotrigine Dispersible Tablets withdrawn immediately unless the rash is clearly not related to lamotrigine treatment. It is recommended that Lamotrigine Dispersible Tablets not be restarted in patients who have discontinued due to rash associated with prior treatment with lamotrigine unless the potential benefit clearly outweighs the risk.

Rashes have also been reported as part of a hypersensitivity syndrome associated with a variable pattern of systemic symptoms including fever, lymphadenopathy, facial oedema and abnormalities of the blood and liver (see section 4.8). The syndrome shows a wide spectrum of clinical severity and may, rarely, lead to disseminated intravascular coagulation (DIC) and multiorgan failure. It is important to note that early manifestations of hypersensitivity (e.g., fever, lymphadenopathy) may be present even though rash is not evident. Patients should be warned to seek immediate medical advice if any of these signs and symptoms develop. Patients should be evaluated immediately should such signs and symptoms and Lamotrigine discontinued if an alternative aetiology cannot be established

Clinical worsening and suicide risk

Suicidal ideation and behaviour have been reported in patients treated with AEDs in several indications. A meta-analysis of randomised placebo-controlled trials of AEDs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for lamotrigine.

Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.

In patients with bipolar disorder, worsening of depressive symptoms and/or the emergence of suicidality may occur whether or not they are taking medications for bipolar disorder, including Lamotrigine Dispersible Tablets. Therefore patients receiving Lamotrigine Dispersible Tablets for bipolar disorder should be closely monitored for clinical worsening (including development of new symptoms) and suicidality, especially at the beginning of a course of treatment, or at the time of dose changes. Certain patients, such as those with a history of suicidal behaviour or thoughts, young adults, and those patients exhibiting a significant degree of suicidal ideation prior to commencement of treatment, may be at a greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients who experience clinical worsening (including development of new symptoms) and/or the emergence of suicidal ideation/behaviour, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.

Hormonal contraceptives

Effects of hormonal contraceptives on lamotrigine efficacy

The use of an ethinyloestradiol/levonorgestrel (30µg/150µg) combination increases the clearance of lamotrigine by approximately two-fold resulting in decreased lamotrigine levels (see section 4.5). A decrease in lamotrigine levels has been associated with loss of seizure control. Following titration, higher maintenance doses of lamotrigine (by as much as two-fold) will be needed in most cases to attain a maximal therapeutic response. When stopping hormonal contraceptives, the clearance of lamotrigine may be halved. Increases in lamotrigine concentrations may be associated with dose-related adverse events.

Patients should be monitored with respect to this.

In women not already taking an inducer of lamotrigine glucuronidation and taking a hormonal contraceptive that includes one week of inactive treatment (for example "pill-free week"), gradual transient increases in lamotrigine levels will occur during the week of inactive treatment (see section 4.2). Variations in lamotrigine levels of this order may be associated with adverse effects. Therefore, consideration should be given to using contraception without a pill-free week, as first-line therapy (for example, continuous hormonal contraceptives or non-hormonal methods).

The interaction between other oral contraceptive or HRT treatments and lamotrigine have not been studied, though they may similarly affect lamotrigine pharmacokinetic parameters.

Effects of lamotrigine on hormonal contraceptive efficacy

An interaction study in 16 healthy volunteers has shown that when lamotrigine and a hormonal contraceptive (ethinyloestradiol/levonorgestrel combination) are administered in combination, there is a modest increase in levonorgestrel clearance and changes in serum FSH and LH (see section 4.5). The impact of these changes on ovarian ovulatory activity is unkown. However, the possibility of these changes resulting in decreased contraceptive efficacy in some patients taking hormonal preparations with lamotrigine cannot be excluded. Therefore patients should be instructed to promptly report changes in their menstrual pattern, i.e. breakthrough bleeding.

Dihydrofolate reductase

Lamotrigine is a weak inhibitor of dihydrofolate reductase hence there is a possibility of interference with folate metabolism during long-term therapy. However, during prolonged human dosing, lamotrigine did not induce significant changes in the haemoglobin concentration, mean corpuscular volume, or serum or red blood cell folate concentrations for up to 1 year or red blood cell folate concentrations for up to 5 years.

Renal failure

In patients with end stage renal failure, single dose studies showed that plasma concentrations of lamotrigine were not significantly altered. However, accumulation of the glucuronide metabolite is to be expected; caution should therefore be exercised in treating patients with renal failure.

Patients taking other preparations containing lamotrigine

Lamotrigine Dispersible Tablets should not be administered to patients currently being treated with any other preparation containing lamotrigine without consulting a doctor.

Development in children

There are no data on the effect of lamotrigine on growth, sexual maturation and cognitive, emotional and behavioural developments in children.

Precautions relating to epilepsy

As with other AEDs, abrupt withdrawal of Lamotrigine Dispersible Tablets may provoke rebound seizures. Unless safety concerns (for example rash) require an abrupt withdrawal, the dose of Lamotrigine Dispersible Tablets should be gradually decreased over a period of two weeks.

There are reports in the literature that severe convulsive seizues including status epilepticus may lead to rhabdomyolysis, multi organ dysfunction and disseminated intravascular coagulation, sometimes with fatal outcome. Similar cases have occurred in association with the use of lamotrigine.

A clinically significant worsening of seizure frequency instead of an improvement may be observed. In patients with more than one seizure type, the observed benefit of control for one seizure type should be weighed against any observed worsening in another seizure type.

Myoclonic seizures may be worsened by lamotrigine.

There is a suggestion in the data that responses in combination with enzyme inducers is less than in combination with non-enzyme inducing antiepileptic agents. The reason is unclear.

In children taking lamotrigine for the treatment of typical absence seizures, efficacy may not be maintained in all patients.

Precautions relating to bipolar disorder

Children and adolescents below 18 years

Treatment with antidepressants is associated with an increased risk of suicidal thinking and behaviou

iodine and potassium iodide (strong iodine)

EYE-oh-dine, poe-TAS-ee-um EYE-oh-dide

Available Dosage Forms:

• Solution

Therapeutic Class: Antithyroid Agent

Uses For iodine and potassium iodide (strong iodine)

Strong iodine is used to treat overactive thyroid, iodine deficiency, and to protect the thyroid gland from the effects of radiation from radioactive forms of iodine. It may be used before and after administration of a radioactive medicine containing radioactive iodine or after accidental exposure to radiation (for example, from nuclear power plant accidents). It may also be used for other conditions as determined by your doctor.

Strong iodine is available only with your doctor's prescription.

Before Using iodine and potassium iodide (strong iodine)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For iodine and potassium iodide (strong iodine), the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to iodine and potassium iodide (strong iodine) or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Strong iodine may cause skin rash and thyroid problems in infants.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of strong iodine in the elderly with use in other age groups, iodine and potassium iodide (strong iodine) is not expected to cause different side effects or problems in older people than it does in younger adults.

Breast Feeding

Iodine

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Potassium IodidePotassium Iodide

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking iodine and potassium iodide (strong iodine), it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using iodine and potassium iodide (strong iodine) with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol


• Anisindione


• Dicumarol


• Phenindione


• Phenprocoumon


• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of iodine and potassium iodide (strong iodine). Make sure you tell your doctor if you have any other medical problems, especially:

• Bronchitis or


• Other lung conditions—Use of strong iodine may make this condition worse

• Hyperkalemia (too much potassium in the blood) or


• Kidney disease—Use of strong iodine may increase the amount of potassium in the blood and increase the chance of side effects

Proper Use of iodine and potassium iodide (strong iodine)

For patients taking iodine and potassium iodide (strong iodine) for radiation exposure:

• Take iodine and potassium iodide (strong iodine) only when directed to do so by state or local public health authorities.


• Take iodine and potassium iodide (strong iodine) once a day for 10 days, unless otherwise directed by public health authorities. Do not take more of it and do not take it more often than directed. Taking more of the medicine will not protect you better and may result in a greater chance of side effects.

If strong iodine upsets your stomach, take it after meals or with food or milk unless otherwise directed by your doctor. If stomach upset (nausea, vomiting, stomach pain, or diarrhea) continues, check with your doctor.

iodine and potassium iodide (strong iodine) is to be taken by mouth even if it comes in a dropper bottle.

Do not use this solution if it turns brownish yellow.

Take strong iodine in a full glass (8 ounces) of water or in fruit juice, milk, or broth to improve the taste and lessen stomach upset. Be sure to drink all of the liquid to get the full dose of medicine.

If crystals form in strong iodine solution, they may be dissolved by warming the closed container of solution in warm water and then gently shaking the container.

Dosing

The dose of iodine and potassium iodide (strong iodine) will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of iodine and potassium iodide (strong iodine). If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (solution):
  
  • To treat overactive thyroid (hyperthyroid):
    
    • Adults and teenagers—One milliliter (mL) three times a day. The first dose is taken at least one hour after the first dose of your antithyroid medicine.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To prepare for surgery to remove thyroid gland:
    
    • Adults, teenagers, and children—3 to 5 drops (approximately 0.1 to 0.3 mL) three times a day for ten days before surgery. iodine and potassium iodide (strong iodine) is usually given along with your antithyroid medicine.
    
    
  
  
  • To protect the thyroid gland against radiation exposure:
    
    • Adults and teenagers—130 mg once a day for ten days.
    
    
    • Children—65 mg once a day for ten days.
    
    
  
  
  • To treat iodine deficiency:
    
    • Adults and teenagers—0.3 to 1 mL three to four times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of iodine and potassium iodide (strong iodine), take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using iodine and potassium iodide (strong iodine)

Your doctor should check your progress at regular visits to make sure that iodine and potassium iodide (strong iodine) does not cause unwanted effects.

For patients on a low-potassium diet:

• iodine and potassium iodide (strong iodine) contains potassium. Check with your health care professional before you take iodine and potassium iodide (strong iodine).

iodine and potassium iodide (strong iodine) Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Hives


• joint pain


• swelling of the arms, face, legs, lips, tongue, and/or throat


• swelling of the lymph glands

With long-term use

• Burning of mouth or throat


• confusion


• headache (severe)


• increased watering of mouth


• irregular heartbeat


• metallic taste


• numbness, tingling, pain, or weakness in hands or feet


• soreness of teeth and gums


• stomach upset


• symptoms of head cold


• unusual tiredness


• weakness or heaviness of legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Diarrhea


• nausea or vomiting


• stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More iodine and potassium iodide (strong iodine) resources

• Iodine and potassium iodide (strong iodine) Drug Interactions
• Iodine and potassium iodide (strong iodine) Support Group
• 0 Reviews · Be the first to review/rate this drug

IvDerm otic

Generic Name: chloroxylenol, hydrocortisone, and pramoxine (otic) (KLOR oh ZYE nol, HYE droe KOR ti sone, pra MOX een)

Brand Names: Aero Otic HC, Cortamox, Cortane-B, Cortane-B Aqueous, Cortane-B Otic, Cortic-ND, Cyotic, Exotic-HC, Hydro Ear, IvDerm, Otirx, Oto-End, Otomar HC, Tri-Otic, Zolene HC, Zoto-HC Drops

What is IvDerm (chloroxylenol, hydrocortisone, and pramoxine (otic))?

Chloroxylenol is an antibiotic that fights bacteria.

Pramoxine is a topical anesthetic. It works by interfering with pain signals sent from the nerves to the brain.

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

The combination of chloroxylenol, hydrocortisone, and pramoxine otic (for the ear) are used to treat pain, and swelling caused by ear infections.

Chloroxylenol, hydrocortisone, and pramoxine otic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about IvDerm (chloroxylenol, hydrocortisone, and pramoxine (otic))?

Do not use this medication if you have a ruptured (torn) ear drum, or the medication could leak into the inner ear. A ruptured ear drum usually causes moderate to severe ear pain, with or without a decrease in hearing. Call your doctor if you think you have a ruptured ear drum. Your doctor will use a special scope to see any tear in your ear drum.

Before using chloroxylenol, hydrocortisone, and pramoxine, tell your doctor if you are allergic to any drugs, or if you have any type of illness or infection (other than an ear infection).

Chloroxylenol, hydrocortisone, and pramoxine otic is for use only in your ear. Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Ear infections may sometimes cause dizziness or a loss of balance. Be careful if you drive, operate machinery, or do anything else hazardous if you feel dizzy or off balance. Stop using this medication and call your doctor at once if you have ear drainage or discharge, severe burning or itching in your ear, or worsening pain, irritation, or rash.

Less serious side effects are more likely, and you may have none at all.

What should I discuss with my healthcare provider before using IvDerm (chloroxylenol, hydrocortisone, and pramoxine (otic))?

You should not use this medication if you are allergic to chloroxylenol, hydrocortisone, or pramoxine.

Do not use this medication if you have a ruptured (torn) ear drum, or the medication could leak into the inner ear. A ruptured ear drum usually causes moderate to severe ear pain, with or without a decrease in hearing. Call your doctor if you think you have a ruptured ear drum. Your doctor will use a special scope to see any tear in your ear drum.

Before using chloroxylenol, hydrocortisone, and pramoxine, tell your doctor if you are allergic to any drugs, or if you have any type of illness or infection (other than an ear infection).

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether chloroxylenol, hydrocortisone, and pramoxine otic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use my IvDerm (chloroxylenol, hydrocortisone, and pramoxine (otic))?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.

Do not use the medication in your eyes or take it by mouth. Chloroxylenol, hydrocortisone, and pramoxine otic is for use in the ears only.

For best results, remove any ear wax or other debris before using the ear drops. Ask your doctor about safe methods of ear wax removal.

To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. Hold the dropper upside down over your ear canal and place enough drops of the medicine in your ear to fill the ear canal.

Do not place the dropper tip into your ear, or allow the tip to touch any surface. It may become contaminated.

After using the ear drops, keep the ear tilted upward for about 5 minutes. You may also be able to soak a small cotton wick with the medication and leave it in place. Ask your doctor of pharmacist for instructions on using a cotton wick.

Wipe the dropper tip with a clean tissue. Do not wash the tip with water or soap.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after using this medication.

Store the ear drops at room temperature away from moisture and heat. Keep the bottle properly capped.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of chloroxylenol, hydrocortisone, and pramoxine applied into the ear is not likely to cause life-threatening symptoms.

What should I avoid while using this medication?

Do not use other ear drops during treatment with chloroxylenol, hydrocortisone, and pramoxine otic without first talking to your doctor. Ear infections may sometimes cause dizziness or a loss of balance. Be careful if you drive, operate machinery, or do anything else hazardous if you feel dizzy or off balance. Chloroxylenol, hydrocortisone, and pramoxine otic is for use only in your ear. Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water.

IvDerm (chloroxylenol, hydrocortisone, and pramoxine (otic)) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  ear drainage or discharge;

  
  


• 
  

  severe burning or itching in your ear; or

  
  


• 
  

  worsening pain, irritation, or rash.

  
  

Less serious side effects are more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect my IvDerm (chloroxylenol, hydrocortisone, and pramoxine (otic))?

It is not likely that other drugs you take orally or inject will have an effect on chloroxylenol, hydrocortisone, and hydrocortisone otic. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More IvDerm resources

• IvDerm Use in Pregnancy & Breastfeeding
• IvDerm Support Group
• 0 Reviews for IvDerm - Add your own review/rating

Compare IvDerm with other medications

• Acute Otitis Externa
• Ear Conditions
• Otitis Externa

Where can I get more information?

• Your pharmacist can provide more information about chloroxylenol, hydrocortisone, and pramoxine otic.

Valcyte

Generic Name: valganciclovir (Oral route)

val-gan-SYE-kloe-vir

Oral route(Tablet;Powder for Solution)

The clinical toxicity of valganciclovir, which is metabolized to ganciclovir, includes granulocytopenia, anemia and thrombocytopenia. In animal studies, ganciclovir was carcinogenic, teratogenic, and caused aspermatogenesis .

Commonly used brand name(s)

In the U.S.

• Valcyte

Available Dosage Forms:

• Powder for Solution


• Tablet

Therapeutic Class: Antiviral

Pharmacologic Class: Viral DNA Polymerase Inhibitor

Chemical Class: Guanosine Nucleoside Analog

Uses For Valcyte

Valganciclovir is used to treat symptoms of cytomegalovirus (CMV) retinitis, an infection in the eyes of people with acquired immunodeficiency syndrome (AIDS). Valganciclovir will not cure this eye infection, but it may help to keep the symptoms from becoming worse.

Valganciclovir is an antiviral. It is used to treat infections caused by viruses. This medicine is also used to prevent CMV disease in patients who have received an organ transplant (e.g., heart, kidney, or kidney-pancreas transplant).

This medicine may cause some serious side effects, including anemia and other blood problems. Before you begin treatment with valganciclovir, you and your doctor should talk about the benefit this medicine will do as well as the risks of using it.

This medicine is available only with your doctor's prescription.

Before Using Valcyte

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of valganciclovir for the prevention of CMV disease in kidney and heart transplant children. However, safety and efficacy of valganciclovir for the prevention of CMV disease have not been established in liver transplant children, and in kidney and heart transplant infants less than 4 months of age.

Geriatric

Although appropriate studies on the relationship of age to the effects of valganciclovir have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving valganciclovir.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Imipenem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Didanosine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• High Fat Food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood or bone marrow problems (e.g., anemia, bone marrow aplasia, leukopenia, neutropenia, pancytopenia, thrombocytopenia)—Use with caution. May make these conditions worse. or

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Kidney disease, severe (hemodialysis)—Should not be used in patients with this condition.

Proper Use of Valcyte

Take this medicine exactly as directed by your doctor. Do not change the dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

This medicine should come with a patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

It is important that you take this medicine with food. This is to make sure the medicine is fully absorbed into the body and will work properly.

Swallow the tablet whole. Do not break, crush, or chew it.

Be careful not to handle crushed or broken tablets. If you have contact with broken or crushed tablets or mixed oral liquid, wash your skin with soap and clear water. If the medicine gets into your eyes, rinse them with clear water.

If you are using the oral liquid, use the oral dispenser that comes with the package to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

If you are taking ganciclovir (Cytovene®) capsules before switching to valganciclovir (Valcyte®) tablets, the dose of your medicine may change. Although these medicines both treat the same problem, they are absorbed differently by your body. Make sure you understand the new directions for Valcyte® so you do not take too many tablets.

To get the best results, valganciclovir must be given for the full time of treatment. Also, this medicine works best when there is a constant amount in the blood. To help keep the amount constant, valganciclovir must be taken on a regular schedule.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (solution and tablets):
  
  • For treatment of CMV infection in the eyes:
    
    • Adults—At first, 900 milligrams (mg) (two 450 mg tablets) two times a day for 21 days. Then, your doctor may adjust your dose to 900 mg once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For prevention of CMV disease in transplant patients:
    
    • Adults who have received heart or kidney-pancreas transplant—900 milligrams (mg) (two 450 mg tablets) once a day starting within 10 days of transplantation until 100 days after transplantation.
    
    
    • Adults who have received kidney transplant—900 mg (two 450 mg tablets) once a day starting within 10 days of transplantation until 200 days after transplantation.
    
    
    • Teenagers and children 4 months to 16 years of age who have received heart or kidney transplant—Dose given once a day starting within 10 days of transplantation until 100 days after transplantation is based on body size and creatinine clearance which must be determined by your doctor. However, the dose is usually not more than 900 mg once a day.
    
    
    • Infants younger than 4 months old—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the mixed oral liquid in the refrigerator. Do not freeze. Throw away any unused medicine after 49 days through community take-back programs when available.

Precautions While Using Valcyte

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are taking this medicine and for at least 1 month after stopping it. Also, men should use a condom during treatment with this medicine and for at least 90 days after treatment has been completed. If you think you have become pregnant while using the medicine, tell your doctor right away.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

Valganciclovir can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause kidney failure, especially in elderly patients with kidney problems. Check with your doctor right away if you have the following symptoms: agitation, coma, confusion, decreased urine output, depression, dizziness, headache, hostility, irritability, lethargy, muscle twitching, nausea, rapid weight gain, seizures, stupor, or swelling of the face, ankles, or hands.

This medicine may cause confusion, seizures, dizziness, drowsiness, or trouble in controlling movements. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Valcyte Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Black, tarry stools


• blood in the urine or stools


• blurred vision


• chills


• cough


• dizziness


• fever


• headache


• hoarseness


• lower back or side pain


• nervousness


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


• pounding in the ears


• seeing flashes or sparks of light


• seeing floating spots before the eyes


• shakiness in the legs, arms, hands, or feet


• shortness of breath


• slow or fast heartbeat


• sore throat


• trembling or shaking of the hands or feet


• troubled breathing


• troubled breathing with exertion


• ulcers, sores, or white spots in the mouth


• unusual bleeding or bruising


• unusual tiredness or weakness


• veil or curtain appearing across part of vision

Less common

• Changes in facial skin color


• confusion


• false beliefs


• fast or irregular breathing


• feeling, hearing, or seeing things that are not there


• hives, itching, and skin rash


• large, hive-like swellings on the eyelids, face, lips, mouth, or tongue


• puffiness or swelling of the eyelids or around the eyes


• runny or stuffy nose


• seizures


• tightness in the chest or wheezing


• trouble thinking

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain


• diarrhea


• headache


• nausea and vomiting


• numbness, tingling, pain, or weakness of the hands or feet


• sleeplessness


• tingling, burning, or prickly sensations


• trouble with sleeping


• unsteadiness or awkwardness

Less common

• Agitation

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Valcyte side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Valcyte resources

• Valcyte Side Effects (in more detail)
• Valcyte Use in Pregnancy & Breastfeeding
• Drug Images
• Valcyte Drug Interactions
• Valcyte Support Group
• 0 Reviews for Valcyte - Add your own review/rating

• Valcyte Prescribing Information (FDA)


• Valcyte MedFacts Consumer Leaflet (Wolters Kluwer)


• Valcyte Concise Consumer Information (Cerner Multum)


• Valcyte Monograph (AHFS DI)


• Valganciclovir Professional Patient Advice (Wolters Kluwer)

Compare Valcyte with other medications

• CMV Retinitis
• Cytomegalovirus Infection

Gentamicin Eye / Ear Drops 0.3% W / V

1. Name Of The Medicinal Product

Gentamicin Eye/Ear Drops 0.3% W/V

2. Qualitative And Quantitative Composition

Active Ingredient

Gentamicin sulphate equivalent to 30mg gentamicin base in 10ml of solution

3. Pharmaceutical Form

Eye/Ear Drops

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of infections of the external structures of the eye and its adnexa caused by susceptible bacteria. Such infections include conjunctivitis, keratitis, kerato-conjunctivitis, corneal ulcers, blepharitis and blepharo-conjunctivitis, acute meibomianitis, episcleritis and dacryocystitis. It may be used for the prevention of ocular infection after: removal of a foreign body, burns or lacerations of the conjunctiva; damage from chemical or physical agents and after ocular surgery.

Also indicated for the treatment of otitis externa.

4.2 Posology And Method Of Administration

Eye: Instill 1-2 drops into the affected eye every four hours as required.

Ears: The area should be cleansed and 2-4 drops instilled 3-4 times daily.

4.3 Contraindications

Should not be administered to patients with a known allergy to gentamicin and other aminoglycosides. Evidence exists that gentamicin may cause neuromuscular blockade and is therefore contra-indicated in myasthenia gravis and related conditions.

Perforated tympanic membrane.

4.4 Special Warnings And Precautions For Use

Avoid prolonged use. Not for use with contact lenses

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Potent diuretics such as ethacrynic acid and frusemide are believed to enhance any risk of ototoxicity whilst amphotericin B, cisplatin and cyclosporin are potential enhancers of nephrotoxicity.

Neuromuscular blockade and respiratory paralysis have been reported in patients from the administration of aminoglycosides to patients who have received curare-type muscle relaxants during anaesthesia.

4.6 Pregnancy And Lactation

There are no proven cases of intrauterine damage caused by gentamicin. However, in common with most drugs known to cross the placenta, usage in pregnancy should only be considered in life-threatening situations where expected benefits outweigh possible risks.

In the absence of gastrointestinal inflammation the amount of gentamicin ingested from the milk is unlikely to result in significant blood levels in breast-fed infants.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Severe dose-related ototoxicity can occur with gentamicin in susceptible patients, particularly those with renal impairment.

Vestibular damage is more common than hearing loss. Reversible nephrotoxicity may occur and acute renal failure has been reported, often in association with concurrent administration of cephalosporins.

Gentamicin drops may cause transient eye irritation or local sensitivity in the ear.

4.9 Overdose

Haemodialysis and peritoneal dialysis will aid the removal from blood but the former is probably more efficient. Calcium salts given intravenously have been used to counter the neuromuscular blockade caused by gentamicin.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Gentamicin is a mixture of antibiotic substances produced by the growth of micromonospora purpurea. It is bactericidal with greater antibacterial activity than streptomycin, neomycin or kanamycin.

Gentamicin exerts a number of effects on cells of susceptible bacteria. It affects the integrity of the plasma membrane and the metabolism of RNA, but it's most important effect is inhibition of protein synthesis at the level of the 30s ribosomal subunit.

5.2 Pharmacokinetic Properties

Gentamicin is not readily absorbed from the gastro-intestinal tract. Gentamicin is 70-85% bound to plasma albumin following administration and is excreted 90% unchanged in urine. The half-life for its elimination in normal patients is 2 to 3 hours.

Effective plasma concentration is 4 - 8ug/ml

The volume of distribution (^VD) is 0.3 l/kg

The elimination rate constant is;

0.02 Hr-1 for anuric patients* 0.30 Hr-1 normal

* Therefore in those with anuria care must be exercised.

5.3 Preclinical Safety Data

Nothing of relevance which is not included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium Chloride

Disodium Edetate

Sodium Metabisulphite

Borax

Benzalkonium Chloride solution

Purified Water

Sodium Hydroxide soluion (pH adjuster)

Hydrochloric acid (pH adjuster)

6.2 Incompatibilities

Pharmaceutically incompatible with amphotericin, cephalosporins, erythromicin, heparin penicillins, sodium bicarbonate and sulphadiazine sodium.

6.3 Shelf Life

Unopened:	36 months
Opened:	28 days

6.4 Special Precautions For Storage

Protect from light.

Store below 25ºC

6.5 Nature And Contents Of Container

10ml polypropylene dropper bottle fitted with an LDPE nozzle and an HDPE tamper evident cap.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

FDC International Ltd

Unit 6 Fulcrum 1

Solent Way

Whiteley

Fareham

Hants

PO15 7FE

United Kingdom

8. Marketing Authorisation Number(S)

PL 15872/0004

9. Date Of First Authorisation/Renewal Of The Authorisation

22 January 1998/ 18 March 2003

10. Date Of Revision Of The Text

17 June 2009

Zonegran

Pronunciation: zoe-NIS-a-mide
Generic Name: Zonisamide
Brand Name: Zonegran

Zonegran is used for:

Treating certain types of seizures (partial seizures) in patients with epilepsy. It is used along with other medicines. It may also be used for other conditions as determined by your doctor.

Zonegran is an anticonvulsant. Exactly how Zonegran works is not known.

Do NOT use Zonegran if:

• you are allergic to any ingredient in Zonegran or to a sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, or valdecoxib


• you have kidney failure

Contact your doctor or health care provider right away if any of these apply to you.

Before using Zonegran:

Some medical conditions may interact with Zonegran. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances (including tartrazine)


• if you are allergic to aspirin


• if you have a history of status epilepticus (eg, long periods of continuous seizure activity or a series of seizures without a full return to consciousness)


• if you have a history of liver or kidney problems, kidney stones, lung or breathing problems, mental or mood problems (eg, depression), or suicidal thoughts or actions


• if you have a skin rash


• if you have diarrhea, will be having surgery, or are on a ketogenic diet

Some MEDICINES MAY INTERACT with Zonegran. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticholinergics (eg, benztropine) or carbonic anhydrase inhibitors (eg, acetazolamide) because the risk of heatstroke or high blood acid levels may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zonegran may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zonegran:

Use Zonegran as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Zonegran comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Zonegran refilled.


• Take Zonegran by mouth with or without food.


• Swallow Zonegran whole. Do not break, crush, or chew before swallowing.


• Drink plenty of liquids (6 to 8 glasses of water per day) while taking Zonegran to help prevent kidney stones.


• Do not suddenly stop taking Zonegran. Suddenly stopping Zonegran may cause seizures to occur more often. If you need to stop Zonegran, your doctor will gradually lower your dose.


• If you miss a dose of Zonegran, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Zonegran.

Important safety information:

• Zonegran may cause dizziness, drowsiness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Zonegran with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Zonegran may reduce sweating, which could increase the risk of heat stroke, especially in children. The risk is greater in hot weather and/or during vigorous exercise. Drink plenty of fluids. Dress lightly while in hot climates or when exercising. Check carefully for signs of decreased sweating. If this occurs, promptly seek cooler or air-conditioned shelter and/or stop exercising. Seek medical attention right away if you have an unexplained fever, mental or mood changes, headache, or dizziness.


• Zonegran may cause high blood acid levels (metabolic acidosis). The risk may be greater in children and in patients with kidney problems, status epilepticus, severe breathing problems, or diarrhea. It may also be greater in patients who are taking certain other medicines (eg, acetazolamide), will be having surgery, or are on a ketogenic diet. Over a period of time, metabolic acidosis may cause kidney problems, bone problems, or decreased growth in children. Contact your doctor immediately if you experience fast breathing, unusual weakness or fatigue, sluggishness, fainting, persistent loss of appetite, or irregular heartbeat.


• Patients who take Zonegran may be at increased risk of suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Zonegran closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.


• Contact your doctor right away if your seizures worsen or if you develop a skin rash.


• Tell your doctor or dentist that you take Zonegran before you receive any medical or dental care, emergency care, or surgery.


• Carry an ID card at all times that says you take Zonegran.


• This product may contain tartrazine dye (FD&C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.


• Women who take Zonegran should use effective birth control while using Zonegran.


• Lab tests, including kidney function or blood bicarbonate levels, may be performed while you use Zonegran. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Zonegran with caution in the ELDERLY; they may be more sensitive to its effects.


• Zonegran should be used with extreme caution in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed. CHILDREN may be at a higher risk of heatstroke, kidney stones, decreased growth, and metabolic acidosis.


• PREGNANCY AND BREAST-FEEDING: Zonegran may cause harm to the fetus. Do not become pregnant while you are using it. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zonegran while you are pregnant. It is not known if Zonegran is found in breast milk. If you are or will be breast-feeding while you use Zonegran, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Zonegran:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensations; diarrhea; dizziness; drowsiness; flu-like symptoms; headache; irritability; loss of appetite; nausea; stomach upset; tiredness; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone pain; change in the amount of urine produced; confusion; dark or bloody urine; decreased sweating; double vision or other vision problems; fainting; fast breathing; fast, slow, or irregular heartbeat; fever, chills, cough, or sore throat; loss of coordination; memory problems; mouth sores; new or worsening mental or mood changes (eg, depression, agitation, anxiety, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, inability to sit still); new or worsening seizures; painful urination; persistent loss of appetite; red, swollen, blistered, or peeling skin; severe muscle pain or weakness; severe or persistent drowsiness; sluggishness; sudden stomach or back pain; suicidal thoughts or actions; swelling of the hands, ankles, or feet; tremor; trouble speaking or other speech problems; trouble thinking or concentrating; unusual bruising or bleeding; unusual eye movements; unusual or disturbing thoughts; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Zonegran side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include difficult, slow, or shallow breathing; severe or persistent dizziness; slow heartbeat; weakness.

Proper storage of Zonegran:

Store Zonegran at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zonegran out of the reach of children and away from pets.

General information:

• If you have any questions about Zonegran, please talk with your doctor, pharmacist, or other health care provider.


• Zonegran is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Zonegran. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Zonegran resources

• Zonegran Side Effects (in more detail)
• Zonegran Use in Pregnancy & Breastfeeding
• Drug Images
• Zonegran Drug Interactions
• Zonegran Support Group
• 18 Reviews for Zonegran - Add your own review/rating

• Zonegran Prescribing Information (FDA)


• Zonegran Consumer Overview


• Zonegran Monograph (AHFS DI)


• Zonegran Advanced Consumer (Micromedex) - Includes Dosage Information


• Zonisamide Professional Patient Advice (Wolters Kluwer)

Compare Zonegran with other medications

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