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Viskodol

Visko Pharmacy Limited
9/26 Udi Road Asata, Enugu, Enugu State, Nigeria.
Email: nnamdi@viskopharm.org
Tel: 234-80-35085021, 234-70-31601265, 234-80-37430071
Website: http://visko.biz/

Brand Name

Viskodol

Manufacturer

Makcur Laboratories Limited

46/5-6-7, Village-Zak, Tal-Dehgam; Dist: Gandhinagar-30, Gajarat (lndia)

Therapeutic Class

Analgesics, Opioids

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Injection (NRN:A4-6672): Tramadol 50 mg

Pack size: 10 x 2 mL.

Pharmacology

Tramadol hydrochloride is a centrally-acting synthetic opioid analgesic binding to specific opioid receptors. It is a non-selective, pure agonist at mu, delta and kappa opioid receptors with a higher affinity for the mu receptor. Other mechanisms, which may contribute to its analgesic effect, are inhibition of neuronal re-uptake of noradrenaline and enhancement of serotonin release.Tramadol hydrochloride dose not promote histamine release.

Indications

VISKODOL INJECTION is indicated for the management of moderate to moderately severe pain.

Contra-indications

Hypersensitivity to Tramadol Hydrochloride or Opoids. Acute intoxification with alcohol, hypnotics, analgesic opioids or psychotropic medicines (due to the risk of respiratory depression).Patients taking monoamine oxidase (MAO)inhibitors or within two week of their discontinuation.

Narcotic withdrawal treatment. Respiratory depression especially in the presence of cyanosis and excessive intracranial pressure or central nervous depression due to head injury or cerebral disease. Pregnancy and lactation.

Precautions/Warnings

Gastrointestinal disorders: Frequent: Nausea, vomiting, dry mouth, dyspepsia, constipation, diarrhoea, anorexia, abdominal pain.

Renal and urinary disorders: Less frequent: Urinary retention, urinary frequency.

Hepato-biliary disorders:

Less frequent: Increase in liver enzymes.

Eye disorders:

Less frequent: Blurred vision.

Skin and subcutaneous tissue disorders:

Frequent: Sweating (especially when IV administration is too rapid), skin rashes, pruritus.

Less frequent: Vesicles, urticaria

Others:

Less frequent: Angioedema, bronchospasm, anaphylaxis, and anaphylactoid reactions. These reactions may occur after the first dose. Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome have been reported. The administration of VISKODOL INJECTION concurrently with other central nervous system medicines is likely to intensify and prolong CNS effect (see INTERACTIONS).

Patients should be warned not to operate machinery or drive a car while using VISKODOL INJECTION. The possibility of respiratory depression cannot be excluded if the recommended dose is exceeded or other centrally depressant medicines are given concomitantly VISKODOL INJECTION should not be used for the treatment of minor pain.

Interactions

Monoamine oxidase inhibitors (MAOls): Because of its inhibitory effect on serotonin uptake, VISKODOL INJECTION should not be used concomitantly with MAOls or within 14 days after discontinuing such treatment

Central nervous system (CNS) depression-producing medications, including alcohol and anaesthetics: Caution is recommended because concurrent use may potentiate the CNS depressant effects. The duration of anaesthesia may be prolonged when VISKODOL INJECTION is combined with barbiturates.

Carbamazepine: Serum concentrations of VISKODOL INJECTION are reduced by carbamazepine, resulting in diminished analgesic activity of VISKODOL INJECTION. lnhibitors of CYP3A4 such as ketoconazole and erythromycin may inhibit the metabolism of Viskodol lnjection.

Adverse Effects

Cardiovascular disorders:

Less frequent: Flushing, syncope, bradycardia, tachycardia, postural hypotension, cardiovascular collapse.

Neurological disorders:

Frequent: Fatigue, sedation, drowsiness, dizziness,headache.

Less frequent: Parasthesia, amnesia confusion, hallucinations, seizures.

Dosage & Administration

The dosage should be adjusted to the intensity of pain and the individual's response to the analgesic action of VISKODOL INJECTION .it should not be used for the treatment of minor pain.

Adults and children over the age of 14 years: 

Paraenteral administration:

  • IV: 1 ampoule (100 mg - injected slowly or diluted in solution for infusion and infused)
  • IM: 1 ampoule (100 mg)
  • SC: 1 ampoule (100 mg)

lntravenous injection must be given slowly over 2 to 3 minutes. A total daily dose of more than 400 mg per day must not be exceeded.

For postoperative pain, administer an initial bolus of 100 mg. During the 90 minutes following the initial bolus further doses of 50 mg may be given every 30 minutes, up to a total dose of 250 mg including the initial bolus. Subsequent doses should be 50 mg or 10 mg 4 to 6 hourly up to a total daily dose of 600 mg. For less severe pain administer 50 mg or 100 mg 4 to 6 hourly.

Elderly:

The usual doses may be used except in patients 75 years of age and over. A downward adjustment of the dose and/or prolongation of the interval between doses are recommended.

Storage/Handling Recommendations

Store below 25oC, protected from light. Keep out of reach of children.

Review Date

2016-10-28 03:57:50