Biogabalin
- Pregabalin
Each capsule contains: 50, 75, 100, 150 mg pregabalin
Pharmaceutical Form: Capsules
Biogabalin Capsules
Composition &Excipients:
Each Capsule contains: 50,75,100,150mg pregabalin
Excipients:lactose monohydrate ,corn starch,talc
Each 1 ml of oral solution contains :20 mg pregabalin
Excipients: methylparaben,propylparaben,monobasic sodium phosphate anhydrous,dibasic sodium phosphate anhydrous,sucralose,artificial strawberry.
Properties :
Biogabalin is an effective medicine. It can offer relief to many people who have been found to have Diabetic Nerve Pain or Pain after Shingles (SHIN-gulls).
Biogabalin was designed just to treat the burning, stabbing, shooting symptoms of nerve pain. When taken as directed, Biogabalin can provide pain relief as soon as 1 week after you start taking it.
Mechanism of Action:
Damaged nerves can send out extra electrical signals. This causes your body to feel pain.
Pregabalin lowers the number of electrical signals in the damaged nerves. This can ease the pain.
Pregabalin binds with high affinity to the alpha 2 -delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues.
In vitro , pregabalin reduces the calcium-dependent release of several neurotransmitters, possibly by modulation of calcium channel function.
While pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), it does not bind directly to GABA A , GABA B , or benzodiazepine receptors, does not augment GABA A responses in cultured neurons.
Pregabalin does not block sodium channels, is not active at opiate receptors, and does not alter cyclooxygenase enzyme activity. It is inactive at serotonin and dopamine receptors and does not inhibit dopamine, serotonin, or noradrenaline reuptake.
Pharmacokinetics :
Following oral administration of pregabalin capsules, peak plasma concentrations occur within 1.5 hours. Pregabalin oral bioavailability is >/=90% and is independent of dose. Following repeated administration, steady state is achieved within 24 to 48 hours. Pregabalin does not bind to plasma proteins.
Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug )approximately 90%( with a mean elimination half-life of 6.3 hours in subjects with normal renal function. Mean renal clearance was estimated to be 67.0 to 80.9 mL/min in young healthy subjects.
Renal Impairment and Hemodialysis:
Pregabalin clearance is nearly proportional to creatinine clearance (CLcr). Dosage reduction in patients with renal dysfunction is necessary.
Pregabalin is effectively removed from plasma by hemodialysis. For patients on hemodialysis, dosing must be modified
Elderly:
Pregabalin oral clearance tended to decrease with increasing age. Reduction of pregabalin dose may be required in patients who have age-related compromised renal function
Indications
Biogabalin is used in adults , 18 years and older, to treat:
- Neuropathic pain associated with diabetic peripheral neuropathy .
- Postherpetic neuralgia .
- Biogabalin is indicated as adjunctive therapy for adult patients with partial
onset seizures
- fibromyalgia.
- neuropathic
Contraindications:
Biogabalin is contraindicated in patients with known hypersensitivity to pregabalin or any of its components.
Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy.
side effects
The most common side effects of Biogabalin are: Dizziness ,Sleepiness ,Dry mouth ,Swelling of hands and feet ,Blurry vision ,Weight gain ,Trouble concentrating .ataxia,confusion,asthenia , incoordination .
These side effects were often mild to moderate. Few people in clinical trials stopped taking Biogabalin because of the side effects.
Be careful about taking Biogabalin with alcohol or with medicines that may make you dizzy or sleepy. You should not drive a car or work with machines until you know how Biogabalin affects you.
WARNINGS
Be sure to tell your doctor if you:
- Are pregnant, plan to become pregnant, or are breast-feeding
- Plan to father a child
- Have any change in your eyesight while taking Biogabalin
- concomitant treatment with Biogabalin and a thiazolidinedione antidiabetic agent( rosiglitazone, pioglitazone) may lead to an additive effect on edema and weight gain. For patients with preexisting cardiac conditions, this may increase the risk of heart failure.
- Have muscle pain along with a tired feeling while taking Biogabalin
- Have skin sores due to diabetes
- Have any kidney problems
- Have any edema or weight gain
Patients should be counseled to take Biogabalin as prescribed. Abrupt or rapid discontinuation may result in insomnia, nausea, headache, or diarrhea
Drug Interactions
Since pregabalin is predominantly excreted unchanged in the urine, and does not bind to plasma proteins, its pharmacokinetics are unlikely to be affected by other agents.
In studies showed that Biogabalin is unlikely to be involved in significant pharmacokinetic drug interactions. Specifically, there are no pharmacokinetic interactions between pregabalin and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate. Important pharmacokinetic interactions would also not be expected to occur between pregabalin and commonly used antiepileptic drugs.
No pharmacokinetic interactions were seen when pregabalin were co-administered with oxycodone, lorazepam, or ethanol .
Pregnancy and lactation
pregabalin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (Category C).
pregabalin should be discontinued during lactation.
Male Fertility:
Inform men who are being treated with BIOGABALIN who plan to father a child at the potential risk of male – mediated teratogenicity .
OVERDOSAGE
The highest reported accidental overdose of pregabalin during the clinical development program was 8000 mg, and there were no notable clinical consequences .
Treatment or Management of Overdose
There is no specific antidote for overdose with pregabalin. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage.
-Hemodialysis may be indicated by the patient ,s clinical state or in patients with significant renal impairment .
DOSAGE AND ADMINISTRATION
BIOGABALIN is given orally with or without food.
Be sure to keep taking BIOGABALIN even after you start feeling relief from your pain. You should talk with your doctor before you stop taking BIOGABALIN or any other prescription medicine.
Neuropathic pain associated with diabetic peripheral neuropathy
The maximum recommended dose of BIOGABALIN is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Dosing should begin at 50 mg three times a day (150 mg/day) and may be increased to 300 mg/day within 1 week based on efficacy and tolerability. the dose should be adjusted for patients with reduced renal function.
When discontinuing BIOGABALIN, taper gradually over a minimum of 1 week.
Postherpetic neuralgia
The recommended dose of BIOGABALIN is 75 to 150 mg two times a day, or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Dosing should begin at 75 mg two times a day, or 50 mg three times a day (150 mg/day) and may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Because BIOGABALIN is eliminated primarily by renal excretion, the dose should be adjusted for patients with reduced renal function .
Epilepsy
BIOGABALIN at doses of 150 to 600 mg/day has been shown to be effective as adjunctive therapy in the treatment of partial onset seizures in adults. The total daily dose should be divided and given either two or three times daily. it is recommended that patients be started on a total daily dose no greater than 150 mg/day (75 mg two times a day, or 50 mg three times a day). Based on individual patient response and tolerability, the dose may be increased to a maximum dose of 600 mg/day.
Oral solution concentration and Dispensing :
The oral solution is 20 mg pregabalin per milliliter (ml) and prescriptions should be written in miligrams (mg) .the pharmacist will calculate the applicable dose in ml for dispensing(e.g .150 mg equals 7.5 ml oral solution .
Patients with Renal Impairment:
In view of dose-dependent adverse events and since BIOGABALIN is eliminated primarily by renal excretion, the dose should be adjusted in patients with reduced renal function.
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PRESENTATION :
Box of 15 or 20 or 30 Capsules pregabalin 50 mg.
Box of 15 or 20 or 30 Capsules pregabalin 100 mg
Box of 15 or 20 or 30 Capsules pregabalin 150 mg