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Kusapin Tablets

Kusapin Tablets

Why you have been prescribed this medicine?

Kusapin is indicated for the treatment of partial seizures with or without secondary generalized tonic-clonic seizures.
Kusapin is indicated for use as monotherapy or adjunctive therapy in adults and children of 6 years of age and above.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:

The most commonly reported adverse reactions are somnolence, headache, dizziness, diplopia, nausea, vomiting and fatigue occurring in more than 10% of patients. The undesirable effect profile by body system is based on AEs from clinical trials assessed as related to Kusapin. In addition, clinically meaningful reports on adverse experiences from named patient programs and post marketing experience were taken into account.

Frequency estimate* :- very common: 1/10; common: 1/100 - < 1/10; uncommon: 1/1,000 - < 1 /100; rare: 1/10,000 - < 1/1,000; very rare: < 1/10,000; unknown: cannot be estimated from the available data. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Blood

and

lymphatic

 

system disorders

 

 

 

 

 

Uncommon

 

Leucopenia

 

 

 

 

Very rare

 

 

Thrombocytopenia

 

 

 

 

Unknown

 

 

Bone marrow depression, aplastic anemia, agranulocytosis,

 

 

 

pancytopenia, neutropenia

 

 

 

 

Immune system disorders

 

 

 

 

 

Very rare

 

 

Hypersensitivity characterised by features such as rash,

 

 

 

 

fever. Other organs or systems may be affected such as

 

 

 

 

blood, lymphatic system, liver, muscles and joints, nervous

 

 

 

 

system, kidney, lungs, angioedema

 

 

 

 

Unknown

 

 

Anaphylactic reactions

 

 

 

 

Metabolism

and

nutrition

 

disorders

 

 

 

 

 

 

 

Common

 

 

Hyponatraemia

 

 

 

 

Very rare

 

 

Hyponatraemia associated with signs and symptoms such as

 

 

 

 

seizures,  confusion,  depressed  level  of  consciousness,

 

 

 

 

encephalopathy, vision disorders, vomiting, nausea

 

 

 

 

Unknown

 

 

Hypothyroidism

 

 

Psychiatric disorders

 

 

 

 

 

Common

 

 

Confusional  state,  depression,  apathy,  agitation  (e.g.

 

 

 

 

nervousness), affect lability

 

 

Nervous system disorders

 

 

 

 

Very common

 

Somnolence, headache, dizziness

 

 

 

 

Common

 

 

Ataxia,  tremor,  nystagmus,  disturbance  in  attention,

 

 

 

 

amnesia

 

 

 

Eye disorders

 

 

 

 

 

Very common

 

Diplopia

 

 

 

 

Common

 

 

Vision blurred, visual disturbance

 

 

 

 

 

Ear

and

 

labyrinth

 

disorders

 

 

 

 

 

 

 

Common

 

 

Vertigo

 

 

 

Cardiac disorders

 

 

 

 

 

 

Very rare

 

 

Arrhythmia, atrioventricular block

 

 

Vascular disorders

 

 

 

 

 

Unknown

 

 

Hypertension

 

 

Gastrointestinal disorders

 

 

 

 

Very common

 

Nausea, vomiting

 

 

 

 

Common

 

 

Diarrhoea, constipation, abdominal pain

 

 

 

 

Very rare

 

 

Pancreatitis and/or lipase and/or amylase increase

 

 

Hepato-biliary disorders

 

 

 

 

 

Very rare

 

 

Hepatitis

 

 

 

 

Skin

and

subcutaneous

 

tissue disorders

 

 

 

 

 

 

Common

 

 

Rash, alopecia, acne

 

 

 

 

 

Uncommon

 

Urticaria

 

 

 

Very rare

 

Angioedema, Stevens-Johnson syndrome, toxic epidermal

 

 

necrolysis (Lyell's syndrome), erythema multiform

 

 

 

Musculoskeletal,

 

 

connective tissue and bone

 

disorders

 

 

 

 

 

Very rare

 

Systemic lupus erythematosus

 

 

 

General   disorders

and

 

administration

site

 

conditions

 

 

 

 

 

Very common

 

Fatigue

 

 

 

Common

 

Asthenia

 

 

 

What to do if you miss a dose?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

Hypersensitivity to the active substance or to any of the Excipients

What to do if you accidentally take too much (overdose) of the medicine?

Isolated cases of overdose have been reported. The maximum dose taken was approximately 24,000 mg. All patients recovered with symptomatic treatment. Symptoms of overdose include somnolence, dizziness, nausea, vomiting, hyperkinesia, hyponatraemia, ataxia and nystagmus. There is no specific antidote. Symptomatic and supportive treatment should be administered as appropriate. Removal of the medicinal product by gastric lavage and/or inactivation by administering activated charcoal should be considered.

Kusapin can be taken with or without food. The tablets are scored and can be broken in two halves in order to make it easier for the patient to swallow the tablet. However, the tablet cannot be divided into equal doses.

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication.
For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

Store below 30°C in dry place

Drug Description

Formulation:
Each film coated tablet contains
Oxcarbazepine ………..300 mg;

Description:
Capsule shape, yellow colored, film coated tablet, having break line on both sides of each tablet.

Indications and dosage.

Indications:
Kusapin is indicated for the treatment of partial seizures with or without secondary generalized tonic-clonic seizures.
Kusapin is indicated for use as monotherapy or adjunctive therapy in adults and children of 6 years of age and above.

Administration and Dosage:
In mono and adjunctive therapy, treatment with Kusapin is initiated with a clinically effective dose given in two divided doses. The dose may be increased depending on the clinical response of the patient. In adjunctive therapy, as the total antiepileptic medicinal product load of the patient is increased, the dose of concomitant antiepileptic medicinal product(s) may need to be reduced and/or the Kusapin dose increased more slowly.

Kusapin can be taken with or without food.
The tablets are scored and can be broken in two halves in order to make it easier for the patient to swallow the tablet. However, the tablet cannot be divided into equal doses.

Adults
Mono and adjunctive therapy:
Kusapin should be initiated with a dose of 600 mg/day (8-10 mg/kg/day) given in 2 divided doses. If clinically indicated, the dose may be increased by a maximum of 600 mg/day increments at approximately weekly intervals from the starting dose to achieve the desired clinical response. Therapeutic effects are seen at doses between 600 mg/day and 2,400 mg/day.

Daily doses from 600 to 2,400 mg/day have been shown to be effective in a controlled adjunctive therapy trial, although most patients were not able to tolerate the 2400 mg/day dose without reduction of concomitant antiepileptic medicinal products, mainly because of CNS-related adverse events. Daily doses above 2400 mg/day have not been studied systematically in clinical trials.

Elderly
Adjustment of the dose is recommended in the elderly with compromised renal function.

Children
In mono and adjunctive therapy:
Kusapin should be initiated with a dose of 8-10 mg/kg/day given in 2 divided doses. In adjunctive therapy, therapeutic effects were seen at a median maintenance dose of approximately 30 mg/kg/day. If clinically indicated, the dose may be increased by a maximum of 10 mg/kg/day increments at approximately weekly intervals from the starting dose, to a maximum dose of 46 mg/kg/day, to achieve the desired clinical response.

Side effects and drug interactions.

ADVERSE REACTIONS:
The most commonly reported adverse reactions are somnolence, headache, dizziness, diplopia, nausea, vomiting and fatigue occurring in more than 10% of patients. The undesirable effect profile by body system is based on AEs from clinical trials assessed as related to Kusapin. In addition, clinically meaningful reports on adverse experiences from named patient programs and post marketing experience were taken into account.

Frequency estimate* :- very common: 1/10; common: 1/100 - < 1/10; uncommon: 1/1,000 - < 1 /100; rare: 1/10,000 - < 1/1,000; very rare: < 1/10,000; unknown: cannot be estimated from the available data. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Blood

and

lymphatic

 

system disorders

 

 

 

 

 

Uncommon

 

Leucopenia

 

 

 

 

Very rare

 

 

Thrombocytopenia

 

 

 

 

Unknown

 

 

Bone marrow depression, aplastic anemia, agranulocytosis,

 

 

 

pancytopenia, neutropenia

 

 

 

 

Immune system disorders

 

 

 

 

 

Very rare

 

 

Hypersensitivity characterised by features such as rash,

 

 

 

 

fever. Other organs or systems may be affected such as

 

 

 

 

blood, lymphatic system, liver, muscles and joints, nervous

 

 

 

 

system, kidney, lungs, angioedema

 

 

 

 

Unknown

 

 

Anaphylactic reactions

 

 

 

 

Metabolism

and

nutrition

 

disorders

 

 

 

 

 

 

 

Common

 

 

Hyponatraemia

 

 

 

 

Very rare

 

 

Hyponatraemia associated with signs and symptoms such as

 

 

 

 

seizures,  confusion,  depressed  level  of  consciousness,

 

 

 

 

encephalopathy, vision disorders, vomiting, nausea

 

 

 

 

Unknown

 

 

Hypothyroidism

 

 

Psychiatric disorders

 

 

 

 

 

Common

 

 

Confusional  state,  depression,  apathy,  agitation  (e.g.

 

 

 

 

nervousness), affect lability

 

 

Nervous system disorders

 

 

 

 

Very common

 

Somnolence, headache, dizziness

 

 

 

 

Common

 

 

Ataxia,  tremor,  nystagmus,  disturbance  in  attention,

 

 

 

 

amnesia

 

 

 

Eye disorders

 

 

 

 

 

Very common

 

Diplopia

 

 

 

 

Common

 

 

Vision blurred, visual disturbance

 

 

 

 

 

Ear

and

 

labyrinth

 

disorders

 

 

 

 

 

 

 

Common

 

 

Vertigo

 

 

 

Cardiac disorders

 

 

 

 

 

 

Very rare

 

 

Arrhythmia, atrioventricular block

 

 

Vascular disorders

 

 

 

 

 

Unknown

 

 

Hypertension

 

 

Gastrointestinal disorders

 

 

 

 

Very common

 

Nausea, vomiting

 

 

 

 

Common

 

 

Diarrhoea, constipation, abdominal pain

 

 

 

 

Very rare

 

 

Pancreatitis and/or lipase and/or amylase increase

 

 

Hepato-biliary disorders

 

 

 

 

 

Very rare

 

 

Hepatitis

 

 

 

 

Skin

and

subcutaneous

 

tissue disorders

 

 

 

 

 

 

Common

 

 

Rash, alopecia, acne

 

 

 

 

 

Uncommon

 

Urticaria

 

 

 

Very rare

 

Angioedema, Stevens-Johnson syndrome, toxic epidermal

 

 

necrolysis (Lyell's syndrome), erythema multiform

 

 

 

Musculoskeletal,

 

 

connective tissue and bone

 

disorders

 

 

 

 

 

Very rare

 

Systemic lupus erythematosus

 

 

 

General   disorders

and

 

administration

site

 

conditions

 

 

 

 

 

Very common

 

Fatigue

 

 

 

Common

 

Asthenia

 

 

 

DRUG INTERACTIONS
Enzyme induction
Oxcarbazepine and its pharmacologically active metabolite (the monohydroxy derivative, MHD) are weak inducers in vitro and in vivo of the cytochrome P450 enzymes CYP3A4 and CYP3A5 responsible for the metabolism of a very large number of drugs, for example, immunosuppressants (e.g. ciclosporin, tacrolimus), oral contraceptives (see below), and some other antiepileptic medicinal products (e.g. carbamazepine) resulting in a lower plasma concentration of these medicinal products.
In vitro, oxcarbazepine and MHD are weak inducers of UDP-glucuronyl transferases (effects on specific enzymes in this family are not known). Therefore, in vivo oxcarbazepine and MHD may have a small inducing effect on the metabolism of medicinal products which are mainly eliminated by conjugation through the UDP-glucuronyl transferases. When initiating treatment with Kusapin or changing the dose, it may take 2 to 3 weeks to reach the new level of induction.
In case of discontinuation of Kusapin therapy, a dose reduction of the concomitant medications may be necessary and should be decided upon by clinical and/or plasma level monitoring. The induction is likely to gradually decrease over 2 to 3 weeks after discontinuation.
Hormonal contraceptives
Kusapin was shown to have an influence on the two components, ethinylestradiol (EE) and levonorgestrel (LNG), of an oral contraceptive. The mean AUC values of EE and LNG were decreased by 48-52 % and 32-52% respectively. Therefore, concurrent use of Kusapin with hormonal contraceptives may render these contraceptives ineffective. Another reliable contraceptive method should be used.

Enzyme inhibition
Oxcarbazepine and MHD inhibit CYP2C19. Therefore, interactions could arise when co-administering high doses of Kusapin with medicinal products that are mainly metabolised by CYP2C19 (e.g. phenytoin). Phenytoin plasma levels increased by up to 40 % when Kusapin was given at doses above 1200 mg/day (see table below summarizing results with other anticonvulsants). In this case, a reduction of co-administered phenytoin may be required.
Antiepileptic medicinal products
Potential interactions between Kusapin and other antiepileptic medicinal products were assessed in clinical studies. The effect of these interactions on mean AUCs and Cmin are summarised in the following table:
Summary of antiepileptic medicinal product interactions with Kusapin

Antiepileptic  medicinal

Influence  of

Kusapin

on

Influence   of   antiepileptic

product

antiepileptic medicinal product

medicinal product on MHD

Co-administered

Concentration

 

 

Concentration

Carbamazepine

0 - 22 % decrease

 

40 % decrease

 

(30

%

increase

of

 

 

carbamazepine-epoxide)

 

 

Clobazam

Not studied

 

 

No influence

Felbamate

Not studied

 

 

No influence

Lamotrigine

Slight decrease

 

 

No influence

Phenobarbitone

14 - 15 % increase

 

30 - 31 % decrease

Phenytoin

0 - 40 % increase

 

29 - 35 % decrease

Valproic acid

No influence

 

 

0 – 18 % decrease

 

 

 

 

 

 


Preliminary results indicate that oxcarbazepine may result in lower lamotrigine concentrations, possibly of importance in children, but the interaction potential of oxcarbazepine appears lower than seen with concomitant enzyme inducing drugs (carbamazepine, phenobarbitone, and phenytoin). Strong inducers of cytochrome P450 enzymes (i.e. carbamazepine, phenytoin and phenobarbitone) have been shown to decrease the plasma levels of MHD (29-40 %) in adults; in children 4 to 12 years of age, MHD clearance increased by approximately 35% when given one of the three enzyme-inducing antiepileptic medicinal products compared to monotherapy. Concomitant therapy of Kusapin and lamotrigine has been associated with an increased risk of adverse events (nausea, somnolence, dizziness and headache). Other medicinal product interactions
Cimetidine, erythromycin, viloxazine, wayfaring and dextropropoxyphene had no effect on the pharmacokinetics of MHD.
The interaction between oxcarbazepine and MAOIs is theoretically possible based on a structural relationship of oxcarbazepine to tricyclic antidepressants. Patients on tricyclic antidepressant therapy were included in clinical trials and no clinically relevant interactions have been observed. The combination of lithium and oxcarbazepine might cause enhanced neurotoxicity.

Warnings and precautions


PRECAUTIONS
Hypersensitivity:
Class I (immediate) hypersensitivity reactions including rash, pruritus, urticaria, angioedema and reports of anaphylaxis have been received in the post-marketing period. Cases of anaphylaxis and angioedema involving the larynx, glottis, lips and eyelids have been reported in patients after taking the first or subsequent doses of Kusapin. If a patient develops these reactions after treatment with Kusapin, the drug should be discontinued and an alternative treatment started.
Dermatological effects: Serious dermatological reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and erythema multiforme, have been reported very rarely in association with Kusapin use. Several isolated cases of recurrence of the serious skin reaction when rechallenged with Kusapin were reported. In case of treatment withdrawal, consideration should be given to replacing Kusapin with other antiepileptic drug therapy to avoid withdrawal seizures. Kusapin should not be restarted in patients who discontinued treatment due to a hypersensitivity reaction.
Hyponatraemia: Experience from clinical trials shows that serum sodium levels returned towards normal when the Kusapin dosage was reduced, discontinued or the patient was treated conservatively (e.g. restricted fluid intake). In patients with pre-existing renal conditions associated with low sodium or in patients treated concomitantly with sodium-lowering medicinal products (e.g. diuretics, desmopressin) as well as NSAIDs (e.g. indometacin), serum sodium levels should be measured prior to initiating therapy. All patients with cardiac insufficiency and secondary heart failure should have regular weight measurements to determine occurrence of fluid retention. In case of fluid retention or worsening of the cardiac condition, serum sodium should be checked.
Hepatic function: Very rare cases of hepatitis have been reported, which in most of the cases resolved favourably. When a hepatic event is suspected, liver function should be evaluated and discontinuation of Kusapin should be considered.
Hematological effects: Very rare reports of agranulocytosis, aplastic anemia and pancytopenia have been seen in patients treated with Kusapin during post-marketing experience. Discontinuation of the medicinal product should be considered if any evidence of significant bone marrow depression develops.
Suicidal behaviour: Suicidal behaviour has been reported in patients treated with antiepileptic agents in several indications. A meta-analysis of randomized placebo controlled trials of antiepileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.

Precautions in usage
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications. A meta-analysis of randomized placebo controlled trials of antiepileptic drugs 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 oxcarbazepine.
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.
Female patients of childbearing age should be warned that the concurrent use of Kusapin with hormonal contraceptives may render this type of contraceptive ineffective. Additional non-hormonal forms of contraception are recommended when using Kusapin.
Caution should be exercised if alcohol is taken in combination with Kusapin therapy, due to a possible additive sedative effect. As with all antiepileptic medicinal products, Kusapin should be withdrawn gradually to minimise the potential of increased seizure frequency.

Overdosage and Contraindications

Overdosage
Isolated cases of overdose have been reported. The maximum dose taken was approximately 24,000 mg. All patients recovered with symptomatic treatment. Symptoms of overdose include somnolence, dizziness, nausea, vomiting, hyperkinesia, hyponatraemia, ataxia and nystagmus. There is no specific antidote. Symptomatic and supportive treatment should be administered as appropriate. Removal of the medicinal product by gastric lavage and/or inactivation by administering activated charcoal should be considered.

Kusapin can be taken with or without food. The tablets are scored and can be broken in two halves in order to make it easier for the patient to swallow the tablet. However, the tablet cannot be divided into equal doses.
Contraindications
Hypersensitivity to the active substance or to any of the Excipients

Clinical pharmacology.

Pharmacokinetics:
Following oral administration of Kusapin, oxcarbazepine is completely absorbed and extensively metabolised to its pharmacologically active metabolite (MHD). In a mass balance study in man, only 2 % of total radioactivity in plasma was due to unchanged oxcarbazepine, approximately 70 % was due to MHD, and the remainder attributable to minor secondary metabolites which were rapidly eliminated.
Food has no effect on the rate and extent of absorption of oxcarbazepine, therefore, Kusapin can be taken with or without food.
Approximately 40 % of MHD, is bound to serum proteins, predominantly to albumin. Binding was independent of the serum concentration within the therapeutically relevant range.
Oxcarbazepine and MHD do not bind to alpha-1-acid glycoprotein.
Oxcarbazepine and MHD cross the placenta. Neonatal and maternal plasma MHD concentrations were similar in one case.
Oxcarbazepine is rapidly reduced by cytosolic enzymes in the liver to MHD, which is primarily responsible for the pharmacological effect of Kusapin. MHD is metabolised further by conjugation with glucuronic acid. Minor amounts (4 % of the dose) are oxidised to the pharmacologically inactive metabolite (10, 11-dihydroxy derivative, DHD).
Oxcarbazepine is cleared from the body mostly in the form of metabolites which are predominantly excreted by the kidneys. More than 95 % of the dose appears in the urine, with less than 1 % as unchanged oxcarbazepine. Faecal excretion accounts for less than 4 % of the administered dose. Approximately 80 % of the dose is excreted in the urine either as glucuronides of MHD (49 %) or as unchanged MHD (27 %), whereas the inactive DHD accounts for approximately 3 % and conjugates of oxcarbazepine account for 13 % of the dose.
Oxcarbazepine is rapidly eliminated from the plasma with apparent half-life values between 1.3 and 2.3 hours. In contrast, the apparent plasma half-life of MHD averaged 9.3 ± 1.8 h.

Storage conditions
Store below 30°C in dry place
Dosage forms and packaging available
Kusapin tablets are supplied in transparent blister PVC film .
Each blister contains 10 tablets and 3 such blisters are packed in a carton along with pack insert.
Caution
Food, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
Name and address of manufacturer/marketing authorization holder
Kusum Healthcare Private Limited
SP 289 (A), RIICO Industrial Area Chopanki, Bhiwadi, India
Imported and distributed by
Kusum Healthcare Private Limited.
Branch Office:
Unit 401, 4th Flr.
Peninsula Court Bldg
8735 Paseo de Roxas
Makati City.
Date of revision of package insert
Not Applicable

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare Pvt Ltd

Regd. Office: D-158A, Okhla Industrial Area

Phase-1, New Delhi-110020, India

Tel: 011-41005147, 40514919

Fax: +91-11-40527575

Email: kusumhealth@kusumhealthcare.com

CIN: U65929DL1997PTC085780

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