Thursday, January 26, 2012

Lametec Tablets | Generic Lamictal | Lamotrigine | Dosage | Uses | Side effects

Lametec Tablets (Generic Lamictal) - Active Ingredient And Chemical structure

The active ingredient contained in Lametec Tablets is Lamotrigine. Lamotrigine is a white to pale cream-colored powder and is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl. The structure is shown below
Structure Of Lamotrigine



Generic Forms and Brand names of Lamictal

Lametec Tablets manufactured by Cipla Ltd., India is an effective treatment for Epilepsy adjunctive and mono therapy, generalized seizures of Lennox-Gastaut syndrome and Bipolar Disorder. Generic Lamictal which has the active ingredient Lamotrigine is also sold under various other brand names.



Lamictal Tablets (Lamotrigine) - Uses

Lamotrigine, an antiepileptic drug (AED) in the form of Lametec Tablets is used to treat the following indications:
Epilepsy-adjunctive therapy in patients 2 years of age or more:
partial seizures.
primary generalized tonic-clonic seizures.
generalized seizures of Lennox-Gastaut syndrome.

Epilepsy—monotherapy in patients 16 years of age or greater:
conversion to monotherapy in patients with partial seizures who are receiving treatment with carbamazepine, phenobarbital, phenytoin, primidone, or valproate as the single AED.

Bipolar Disorder in patients 18 years of age and above:
maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy.


Lametec Tablets (Generic Lamictal) - Preparations

Lametec is available as tablets of 25 mg, 50 mg and 100 mg .Each dispersible tablet contains Lamotrigine 25 mg, 50 mg and 100 mg respectively.


Lametec Tablets - Storage Requirements

Lametec Tablets are to be stored at room temperature (15°C to 30°C). Store away from heat, moisture, and light.


Lametec Tablets (Lamotrigine) - Mechanism of Action

The exact ways by which lamotrigine (Lametec Tablets) exerts its anticonvulsant action are unknown. In animal models that were designed to detect anticonvulsant activity, lamotrigine was effective in preventing seizure spread in the maximum electroshock (MES) and pentylenetetrazol (scMet) tests, and prevented seizures in the visually and electrically evoked after-discharge (EEAD) tests for antiepileptic activity.



Lametec Tablets (Lamotrigine) - Dosage

The Dosage for Lametec Tablets is based on concomitant medications, indication, and the age of the patient. To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations should not be exceeded. Lametec (Lamotrigine) Tablets should be swallowed with water.

Monotherapy with Lametec in patients 16 years of age or more:

Lametec is to be titrated to the targeted dose of 50 mg/day while maintaining the dose of the enzyme-inducing antiepileptic drugs(EIAEDs) at a fixed level. The EIAEDs are then gradually withdrawn over a period of 4 weeks.Recommended maintenance dose of Lametec DT as monotherapy is 500 mg/day given in two divided doses.
Bipolar Disorder:
The recommended initial adult dosage of Lametec DT is 25 mg once daily for 2 weeks, followed by 50 mg once daily for 2 weeks.
The recommended adult (over 12 years) dosage for lametec (mg/day) is given below



 Weeks 1 & 2Weeks 3 & 4Usual Maintenance Dose
With enzyme-inducing antiepileptic drugs(EIAEDs) & No Valproic acid (VPA)50mg/day (Once a day) 100mg/day (Two divided doses) 300mg to 500mg/day (Two divided doses). To achieve maintenence doses may be incresed by 100mg/day every 1-2 weeks
EIAEDs & Valproic acid (VPA) 25 mg every other day 25mg (Once a day) 100mg to 400mg/day (Two divided doses). To achieve maintenence doses may be incresed by 25 mg - 50mg/day every 1-2 weeks
As there exists a risk of rash the initial dose and subsequent dose escalation should not be exceeded.

The recommended dose escalation for lamotrigine (lametec) for children aged 2-12 years (total daily dose in mg/kg body weight/day) on combined drug therapy is given below.

  Weeks 1 & 2 Weeks 3 & Usual Maintenance Dose
With AED regimen containing VPA 0.15mg/kg/day (1 or 2 divided doses) 0.3mg/kg/day (1 or 2 divided doses) 1mg - 5mg/kg/day (Maximum 200mg/day in One or Two divided doses)To achieve maintenence doses may be incresed by 0.5 - 1mg/kg/day every 1-2 weeks
Added to EIAEDs and wirhout VPA 0.6mg/kg/day (2 divided doses) 1.2mg/kg/day (2 divided doses) 5mg - 15mg/kg/day (Maximum 400mg/day in One or Two divided doses)To achieve maintenence doses may be incresed by 2 - 3mg/kg/day every 1-2 weeks
After initial 4 weeks of therapy, the daily dosage of Lametec DT may be doubled at weekly intervals until an effective maintenance dosage of 200 mg daily is reached. The daily dosages should not exceed 200 mg daily.



Lametec DT Tablets - Contraindications

Lametec DT Tablets are contraindicated in patients who have demonstrated hypersensitivity to Lamotrigine or any inactive ingredient present in the medicine.



Side Effects Of Lametec DT Tablets (Generic Lamictal or Lamotrigine)

The common adverse effects (incidence 10% or greater) of Lamotrigine (Lametec DT Tablets) in adult epilepsy clinical studies were dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, rhinitis, and rash.
Additional adverse reactions (incidence 10% or greater) reported in children in epilepsy clinical studies included vomiting, infection, fever, accidental injury, pharyngitis, abdominal pain, and tremor. Most common adverse effects with an incidence rate 5% or more in adult bipolar clinical studies were nausea, insomnia, somnolence, back pain, fatigue, rash, rhinitis, abdominal pain, and xerostomia.



Further Information

Prescribing Information

Monday, January 16, 2012

Chloromycetin Aplicaps | Chloramphenicol Eye Ointment | Dosage | Uses | Side effects

Chloromycetin Aplicaps (Chloramphenicol Eye Ointment) - Active Ingredient And Chemical structure

The active ingredient contained in Chloromycetin Aplicaps is Chloramphenicol. Chloramphenicol is a white to greyish-white or yellowish-white, fine crystalline powder or fine crystals, needles or elongated plates. It is soluble to the extent of 1 in 400 of water, 1 in 2.5 of alcohol, and 1 in 7 of propylene glycol; freely soluble in acetone and ethyl acetate; slightly soluble in ether. The structure is shown below
Structure Of Chloramphenicol



Chloromycetin Aplicaps (Chloramphenicol Eye Ointment) - Uses

Chloramphenicol Eye Ointment in the form of Chloromycetin is a topical antibiotic preparation for the treatment of bacterial conjunctivitis.



Generic Forms and Brand names of Chloramphenicol Eye Ointment

Chloromycetin Aplicaps manufactured by Pfizer Ltd., India is an effective treatment for Ocular bacterial infections caused by organisms susceptible to chloramphenicol.



Chloromycetin Aplicaps - Preparations

Chloromycetin is available as aplicaps of 250 mg. Each Aplicap contains 250 mg of chloramphenicol eye ointment I.P. (1%) in an oleaginous ointment base.



Chloromycetin Aplicaps (Chloramphenicol Eye Ointment) - Storage Requirements

Chloromycetin Aplicaps are to be stored at room temperature (15°C to 30°C). Store away from heat, moisture, and light.



Chloromycetin Aplicaps (Chloramphenicol Eye Ointment) - Dosage

To use Chloramphenicol Eye Ointment , wipe the tip of the the aplicap with alcohol, cut the end with a clean instrument and compress the body to squeeze out the contents. Apply the Chloramphenicol Eye ointment, to the affected eye by placing in the lower conjunctival sac every 3 hours or more frequently if necessary. Continue administration day and night for the first 48 hours, at which time the frequency of application can be decreased. Treatment should be continued for at least 48 hours after the eye appears normal.



Chloromycetin Aplicaps (Chloramphenicol Eye Ointment) - Contraindications

Chloromycetin Aplicaps eye ointment is contraindicated in individuals with a history of hypersensitivity and/or toxic reaction to chloramphenicol or any inactive ingredient present in the medication.




Side Effects Of Chloromycetin Aplicaps (Chloramphenicol Eye Ointment)

Blood dyscrasias have been reported in association with the use of Chloromycetin Aplicaps. Chloramphenicol is absorbed systemically from the eye, and toxicity has been reported following chronic exposure. Dose-related toxicity following a single ocular exposure is unlikely.The most common side effects with Chloramphenicol Eye Ointment are Local irritation which includes subjective symptoms of itching or burning.
More Serious side effects such as angioneurotic oedema, anaphylaxis, urticaria, fever, vesicular and maculopapular dermatitis have been reported in patients sensitive to chloramphenicol. Discontinue promptly if any serious side effects occur.




Further Information

Prescribing Information

Monday, January 9, 2012

Nicotex Chewing Gum | Generic Nicorette | Dosage | Uses | Side effects

Nicotex Chewing Gum (Generic Nicorette) - Active Ingredient And Chemical structure

Nicotex Chewing Gum is designed to provide partial substitution for the nicotine in cigarette smoke, which is believed to be one of the principal factors in the prolonging the smoking habit. Nicotex Gum is intended to cushion the patients against the trauma of withdrawal. The active ingredient contained in is Nicotine Polacrilex . The structure is shown below
Structure Of Nicotine



Nicotex Chewing Gum (Nicotine Gum) - Uses

Nicotine Gum in the form of Generic Nicorette Gum is used as an aid for for smoking cessation therapy. Nicotex Chewing Gum reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.




Generic Forms and Brand names of Nicotine Chewing Gum

Nicotex Chewing Gum manufactured by Cipla Ltd., India is an effective treatment aid in nicotine replacement therapy (NRT), a process which helps smokers quit smoking tobacco. Nicorette which has the active ingredient Nicotine Polacrilex is also sold as Nicoderm, Nicogum, Nicotex and Nicotinell.



Nicotex Chewing Gum - Preparations

Nicotex Gum is available as packs of 10 gum pieces. Each piece of Nicotex Chewing Gum contains either 2 mg or 4 mg of Nicotine polacrilex.



Nicotex Chewing Gum - Storage Requirements

Nicotex Chewing Gum is to be stored at room temperature (15°C to 30°C). Store away from heat, moisture, and light.



Nicotex Chewing Gum (Nicotine Gum)- Dosage

The dosing schedule is given below: Patients smoking 25 or more cigarettes a day, have to use 4 mg nicotine gum whereas patients that were smoking less than 25 cigarettes a day, should use 2 mg nicotine gum. Nicotex Chewing Gum has to be used as per the following 12-week schedule:
Weeks 1-6: One piece of gum every 1-2 hours
Weeks 7-9: One piece of gum every 2-4 hours
Weeks 10-12: One piece of gum every 4-8 hours. Do not use more than 24 pieces of Nicotex gum a day.



How To Use Nicotex Chewing Gum (Generic Nicorette) For Maximum Benefit

Each gum piece of gum has to be chewed very slowly several times.Stop chewing Nicotex Chewing Gum when you get a peppery taste or a slight tingling in the mouth. This usually happens after about 1 minute or 15 chews, but may vary from person to person. Shift the chewing gum to one corner or side of your mouth, and leave it there.
When the peppery taste or tingle is almost gone (in about a minute), again start chewing the gum piece slowly. Stop when the taste or tingle returns and shift the gum to a different place in your mouth every time. Repeat the chewing and shifting process of the gum till most of the nicotine is gone from the Nicotex Chewing Gum. This usually happens in about 30 minutes and the peppery taste or tingle will not return.



Nicotex Chewing Gum (Generic Nicorette) - Contraindications

Nicotex Chewing Gum is contraindicated in patients with a hypersensitivity to nicotine polacrilex or any other inactive ingredients present in the chewing gum. Nicotex Chewing Gum is also contraindicated in pregnancy because of well known adverse effect of nicotine on the fetus. Generic Nicorette is also contraindicated in breast feeding mothers, as nicotine is excreted in breast milk.



Side Effects Of Nicotex Chewing Gum (Generic Nicorette)

The most common side effects of Nicotex Chewing Gum, usually in the early days of treatment are apthous ulcers, throat irritation, excessive salivation and hiccups. These symptoms are usually more frequent and severe with the 4 mg gums than the 2 mg version.
Excessive weight gain is sometimes associated with abstention of smoking. Hence, a patient on Nicorette therapy has to be weighed at regular intervals, and if required suitable modifications in diet should be done.