| Composition |
Lenam (Clllordiazepoxide HCI) is prototype for the benzodiazepine compounds. It is a versatile therapeutic agent of proven value for the relief of anxiety.
Lenam 5: Each capsule contains 5 mg Chlordiazepoxide HCI.
Lenam 10: Each capsule contains 10 mg Chlordiazepoxide HCI.
Lenam 25: Each capsule contains 25 mg Chlordiazepoxide HCI. |
| Pharmacodynamics properties |
Lenam has antianxiety, sedative, appetite-stimulating and weak analgesic actions.
The precise mechanism of action is not known.
The drug blocks EEG arousal from stimulation of the brain stem reticular formation. |
| Therapeutic indications |
| Lenam is indicated for the management of anxiety disorders or for the short-tem relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxioly1ic. |
| Warnings and precautions |
WARNINGS:
Chlordiazepoxide HCI may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a vehicle or operating machinery. Similarly, it may impair mental alertness in children. The concomitant use of alcohol or other central nervous system depressants may have an additive effect.
PRECAUTIONS
In elderly and debilitated patient, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia or oversedation (10 mg or less per day initially, to be increased gradually as needed and tolerated). The usual precautions in treating patients with impaired renal or hepatiC function should be observed. In view of isolated reports associating chlordiazepoxide with exacerbation of porphyria, caution should be exercised in prescribing chlordiazepoxide to patient suffering from this disease.
ADVERSE REACTlONS
Drowsiness, ataxia and confusion have been reported in some patients, particularly the elderly and debilitated. Other adverse reactions reported during therapy include isolated instances of skin eruptions, edema, nausea and constipation, extrapyramidal symptoms. Blood dyscrasias (including agranulocytosis), jaundice and hepatic dysfunction have occasionally been reported during therapy. When Lenam treatment is protracted, periodic blood counts and liver function tests are advisable. |
| Contraindication |
| Lenam is contraindicated in patients with known hypersensitivity to the drug. |
| Pregnancy and lactation |
| This drug should be avoided during the first trimester of pregnancy. |
| DOSAGE & ADMINISTRATION |
ADULTS
Relief of Mild and Moderate Anxiety Disorders and Symptoms of Anxiety: 5 mg or 10 mg, 3 or 4 times daily.
Relief of Severe Anxiety Disorders and Symptoms of Anxiety: 20 mg or 25 mg, 3 or 4 times daily.
Geriatric Patients, or in the presence of debilitating disease: 5 mg, 2 to 4 times daily.
Preoperative Apprehension and Anxiety:
On days preceding surgery, 5 to 10 mg orally, 3 to 4 times daily.
PEDIATRIC PATIENTS
Because of the varied response of pediatric patients to CNS acting drugs, therapy should be initiated with the lowest dose and increased as required. Since clinical experience in pediatric patients under 6 years of age is limited, the use of the drug in this age group is not recommended: 5 mg, 2 to 4 times daily (may be inreased in some pediatric patients to 10 mg, 2 to 3 times daily).
For the relief of withdrawal symptoms of acute alcoholism, the suggested initial dose is 50 to 100 mg. to be followed by repeated doses as needed until agitation is controlled up to 300 mg per day. Dosage should then be reduced to maintenance levels. |
| Overdose |
Manifestations of Lenam overdose include somnolence, confusion, coma and diminished
reflexes.
Pulse and blood pressure should be monitored, as in all cases of drug overdose.
General supportive measures should be employed, along with immediate gastriC lavage intravenous fluids should be administered and an adequate airway maintained.
Hypotension may be combated by the use of norepinephrine or metaraminol.
Flumazenil, is a specific benzodiazepine-receptor antagonist, may be used in situation when an overdose with a benzodiazepine is known or suspected. |
| Package |
Lenam 5: Carton box of 20 capsules blister packed.
Lenam 10: Carton box of 20 capsules blister packed.
Lenam 25: Carton box of 20 capsules blister packed. |
| Storage |
| Store in dry place, between (15-30tC, out of the reach of children. |
