GABA-P 25 Cap

GABA-P Capsule — Pregabalin

Indications

Film-coated tablet is indicated for:

Neuropathic pain associated with diabetic peripheral neuropathy
Postherpetic neuralgia
Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older
Fibromyalgia
Neuropathic pain associated with spinal cord injury

Controlled release tablet is indicated for:

Neuropathic pain associated with diabetic peripheral neuropathy
Postherpetic neuralgia

Mechanism of Action

Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). It does not bind directly to GABAA, GABAB or benzodiazepine receptors. 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 has not been fully elucidated, results in animal studies suggest that binding to the alpha2-delta subunit may be involved in Pregabalin's anti-nociceptive and antiseizure effects.

Contraindications

Pregabalin is contraindicated in patients with known hypersensitivity to Pregabalin or any of its components.

Side Effects

Most common side effects in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain and thinking abnormal (primarily difficulty with concentration/attention). Most common side effects in pediatric patients for the treatment of partial onset seizures are increased weight and increased appetite.

Drug Interactions

Drug interaction with medication: GABA-P is unlikely to be involved in significant pharmacokinetic drug interactions.Drug interaction with food and others: Not applicable.

Pregnancy and Lactation

There are no adequate and well-controlled studies with pregabalin in pregnant women. Pregnant women should be advised of the potential risk to a fetus. Small amounts of pregabalin have been detected in the milk of lactating women. Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment with pregabalin.

Precautions and Warnings

Angioedema (e.g., swelling of the throat, head and neck) can occur and may be associated with life threatening respiratory compromise requiring emergency treatment. GABA-P should be discontinued immediately in these cases. GABA-P should also be discontinued immediately if hypersensitivity reactions (e.g., hives, dyspnea and wheezing) occur. Antiepileptic drugs, including GABA-P, increase the risk of suicidal thoughts or behavior. Respiratory depression may occur with GABA-P when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. Patients need to be monitored and dosage adjusted as appropriate. GABA-P may cause dizziness and somnolence and impair patients ability to drive or operate machinery. Increased seizure frequency or other adverse reactions may occur if GABA-P is rapidly discontinued. GABA-P should be withdrawn gradually over a minimum of 1 week. GABA-P may cause peripheral edema. Caution should be exercised when coadministering GABA-P and thiazolidinedione antidiabetic agents.

Use in Special Populations

Use in children and adolescents: Safety and effectiveness in pediatric patients have not been established for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, neuropathic pain associated with spinal cord injury and fibromyalgia. In case of adjunctive therapy for partial onset seizures, safety and effectiveness in pediatric patients below the age of 1 month have not been established. The safety and effectiveness of GABA-P extended-release tablet in pediatric patients have not been established.

Overdose

In case of overdose with GABA-P, sign and symptoms are reduced consciousness, depression/anxiety, confusional state, agitation and restlessness. Seizures and heart block have also been reported. There is no specific antidote. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; usual precautions should be observed to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.

Storage

Keep in a cool & dry place (below 30°C), protected from light & moisture. Keep out of the reach of children.

Medical Disclaimer: This information is provided for educational purposes only and is not intended as medical advice. Always consult a qualified healthcare professional before starting, changing, or stopping any medication.