Human Health Division (HHD) Products

Product List by Brand Name
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Somalax

Composition

Somalax 250 Tablet: Each tablet contains Carisoprodol USP 250 mg. Somalax 350 Tablet: Each tablet contains Carisoprodol USP 350 mg.

Pharmacology

Carisoprodol is a centrally acting skeletal muscle relaxant that does not directly relax tense skeletal muscle in man. The mode of action of Carisoprodol in relieving acute muscle spasm of local origin has not been clearly identified, but may be related to its sedative properties. In animals, Carisoprodol has been shown to produce muscle relaxation by blocking interneuronal activity and depressing transmission of polysynaptic neurons in the spinal cord and the descending reticular formation of the brain. The onset of action is rapid and lasts four to six hours.

Indication

Somalax is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions.

Dosage & Administration

Adults (18 years and older): The recommended dose of Somalax is 250 mg to 350 mg 3-4 times daily (before or after meal and at bedtime) for up to 2-3 weeks or as directed by the physician.

Contraindication

Carisoprodol is contraindicated in patients with history of acute intermittent prophyria or a hypersensitivity reaction to carbamate such as Meprobamate.

Warnings & Precautions

Carisoprodol is metabolized in the liver and excreted by the kidney. To avoid its excess accumulation, caution should be exercised in administration to patients with compromised liver or kidney function & additive sedative effects is found when used with other CNS depressants including alcohol.

Side Effects

Common side effects are drowsiness, dizziness and headache.

Use in Pregnancy & Lactation

The safety of this drug in pregnancy or lactation has not been established. Therefore, use of this drug in pregnancy, in nursing mothers, or in women of childbearing potential requires that the potential benefits of the drug be weighed against the potential hazards to mother and child. Carisoprodol is present in breast milk of lactating mothers at concentrations two to four times that of maternal plasma. This factor should be taken into account when use of the drug is contemplated in breast-feeding patients.

Use in Children & Adolescents

The efficacy, safety and pharmacokinetics of Carisoprodol in paediatric patients less than 16 years of age have not been established.

Drug Interactions

• Caution should be exercised with patients who take other CNS depressants (eg.- alcohol, benzodiazepines, opioids, tricyclic antidepressants) with Carisoprodol.

• Co-administration of CYP2C19 inhibitors (Omeprazole, Fluvoxamine) with Carisoprodol could result in increased exposure of Carisoprodol. Co-administration of CYP2C19 inducers (Rifampin) with Carisoprodol may result in decreased exposure of Carisoprodol.

Overdosage

Overdosage of Carisoprodol commonly produces CNS depression. Death, coma, respiratory depression, hypotension, seizures have been reported with Carisoprodol overdosage. Basic life support measures should be instituted in Carisoprodol overdose. Induced emesis is not recommended due to the risk of CNS and respiratory depression. Gastric lavage should be considered soon after ingestion (within one hour). Circulatory support should be administered with volume infusion and vasopressor agents if needed. Seizures should be treated with intravenous benzodiazepines and the reoccurrence of seizures may be treated with phenobarbital. In cases of severe CNS depression, airway protective reflexes may be compromised and tracheal intubation should be considered for airway protection and respiratory support.

Storage

Store below 30°C., away from light and in a dry place. Keep all medicines out of the reach of children.

Packing

Somalax 250 Tablet: Each box contains 3x10 tablets in Alu-Alu blister pack and an insert.

Somalax 350 Tablet: Each box contains 3x10 tablets in Alu-Alu blister pack and an insert.

Stedex-C Eye Drops

Composition
Stedex -C  Sterile  Eye/Ear  Drops:  Each  ml  drops  contains 
Chloramphenicol BP 5 mg & Dexamethasone Phosphate USP 1 mg..

Indications
Eye: For steroid-responsive inflammatory ocular condition for which a corticosteriod is indicated and where bacterial infection or a risk of bacterial  ocular  infection  exists.  For  inflammatory  conditions  of  the palpebral and bulbar conjunctiva, cornea and anterior segment of the
globe  where  the  inherent  risk  of  steroid  use  in  certain  infective conjunctivitis  is  accepted  to  obtain  a  diminution  in  edema  and inflammation.  For  chronic  anterior  uveitis  and  corneal  injury  from chemical, radiation or thermal burns, or penetration of foreign bodies.
Ear: Otitis externa, Otitis media and chronic suppurative otitis media.

Dosage & Administration
Eye: 1 or 2 drops is instilled into the affected eyes every 3 or 4 hours, or more  frequently  if  deemed  advisable  by  the  prescribing  physician.
Administration should be continued day and night for the first 48 hours, after  which  the  interval  between  applications  may  be  increased. Treatment should be continued for at least 48 hours after the eye appears normal or as directed by the physician. 

Ear: For all infections two to three drops every two to three hours initially. Frequency should be decreased gradually as warranted by improvement in  clinical  signs.  Care  should  be  taken  not  to  discontinue  therapy prematurely or as directed by the physician.

Syscol Eye Drops

Composition
Syscol™ Sterile Eye Drops: Each ml contains
Polyethylene Glycol 400 USP 4 mg & Propylene
Glycol BP 3 mg.
Preservative: Sodium Perborate BP 0.001%

Indications
Syscol™ Sterile Eye Drops is indicated for the
temporary relief of burning and irritation due to
dryness of the eye.

Dosage and administration
Instill 1 drop 4 times daily in the affected eye(s) or as
needed or as directed by the physician.


Sulderm

Composition:
Sulderm Cream: Each gram cream contains Sulconazole Nitrate USP 10 mg. 

Indication: 
Sulderm Cream is indicated for the treatment of Tinea Pedis (athlete's foot), Tinea Cruris, Tinea Corporis & Pityriasis Versicolor.

Dose & Administration: 
A small amount of cream should be gently massaged into the affected and surrounding skin areas once or twice daily, in case of Tinea Pedis where administration should be twice daily. Early relief of symptoms is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, Tinea Corporis, Tinea Cruris and Tinea Versicolor should be treated for 3 weeks and Tinea Pedis for 4 weeks to reduce the possibility of recurrence. Or as 
directed by the physician.