Nervolin
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- မြန်မာ
Pregabalin + Methylcobalamin Capsules
COMPOSITIONS
Each capsule contains:
Pregabalin: 75mg
Methylcobalamin: 750mcg
DESCRIPTION
It is a combination of Methylcobalamin&Pregabalin for the treatment of neuropathic pains.
Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of Pregabalin is unknown, results with genetically modified mice and with compounds structurally related to Pregabalin (such as Gabapentin) suggest that binding to the alpha2-delta subunit may be involved in Pregabalin’santinociceptive and antiseizure effects in animal models. In vitro, Pregabalin reduces the calcium-dependent releases of several neurotransmitters, possibly by modulation of calcium channel function.
Methylcobalamin is the biologically active form of vitamin B12. Cyanocobalamin (Vitamin B12 ) gets converted into Methylcobalamin in the liver.
INDICATIONS
It is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Neuralgia:
- Peripheral neuropathies
- Diabetic neuropathies
- Intercostals neuralgia
- Entrapment neuropathy
DOSAGE & ADMINISTRATION
Adults: One capsule three time daily.
Children: Not recommended.
CONTRA-INDICATIONS
- It is contraindicated in-patients with known hypersensitivity to Pregabalin&Methylcobalamin.
- Safety and efficacy have not been established in children, pregnancy and lactation.
WARNINGS
If there is no response at all after a certain period of time, it should not be continued for more than one month.
ADVERSE EFFECTS
Pregabalin is well tolerated but a few side effects like fatigue, dizziness, ataxia, weight gain, peripheral edema, dry mouth and somnolence, may occur.
Methylcobalamin is well tolerated. However, a few side effects like GI discomfort e.g. anorexia, nausea or diarrhoea and may be seen after administration of methylcobalamin.
SPECIAL PRECAUTIONS
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- Pregabalin is not generally considered effective in the treatment of absence seizures.
- Special care should be taken by patients driving, operating machinery or performing any hazardous tasks.
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- Not recommended during pregnancy and lactation.
- Not recommended for children
- Methylcobalamin is known to be substantially excreted by the kidney and the risk of Methylcobalamin accumulation and lactic acidosis increases with the degree of impairment of renal function. Thus, patients with serum creatinine levels above the upper limit of normal for their age should not receive Methylcobalamin.
DRUG INTERACTION
Pregabalin:
In Vitro Studies:Pregabalin, at concentrations that were, in general, 10-times those attained in clinical trials, does not inhibit human CYP1A2, CYP2A6, CYP3A4 activity.
The drug interaction studies described in this section were conducted in healthy adults, and across various patient populations.
Gabapentin The Pharmacokinetic interactions of pregabalin and gabapentin were investigated in 12 healthy subjects following concomitant single-dose administration of 100-mg pregabalin and 300-mg gabapentin and in 18 healthy subjects following concomitant multiple-dose administration were unaltered by pregabalincoadministration. The extent of pregabalin absorption was unaffected by gabapentin coadministration, although there was a small reduction in rate of absorption.
- Oral Contraceptive: Pregabalincoadministration (200mg three times a day) had no effect on the steady- state pharmacokinetics of norethindrone and ethinylestradiol( 1mg/35mg, respectively)in healthy subjects.
- Lorazepam: Multiple-dose administration of pregabalin (300mg twice a day) in healthy subjects had no effect on the rate and extent of lorazepam single dose pharmacokinetics and single-dose administration of lorazepam (1 mg) had no effect on the steady-state pharmacokinetics of pregabalin.
- Oxycodone: Multiple-dose administration of pregabalin (300mg twice a day)in a healthy subjects had no effect on the rate and extent of oxycodone single dose pharmacokinetics. Single-dose administration of oxycodone (10mg) had no effect on the steady-state pharmacokinetics of pregabalin.
- Ethanol: Multiple-dose administration of pregabalin (300mg twice a day) in healthy subjects had no effect on the rate and extent of ethanol single-dose pharmacokinetics and single-dose administration of ethanol (0.7 g/kg) had no effect on the steady-state pharmacokinetics of pregabalin.
- Phenytoin, carbamazepine, valproic acid, and lamotrigine: Steady-state trough plasma concentrations of phenytoin, carbamazepin and carbamazepine 10,11 epoxide, valproic acid, and lamotrigine were not affected by concomitant pregabalin (200mg three times a day) administration.
Methylcobalamin:
Well tolerated, no significant drug interaction reported.
OVER DOSAGE
The symptoms consist of drowsiness, dizziness, slurred speech and mild diarrhea. Pregabalin can be removed by hemodialysis.
PACKING
Blister strip of 10 capsules
