Norphenadol

Orphenadine citrate, paracetamol.

Each tablet contains: Orphenadrine Citrate 35mg, Paracetamol 450mg.

Pharmacology: Pharmacodynamics: Paracetamol, a para-aminophenol derivative, is a peripherally acting analgesic with antipyretic and weak anti-inflammatory activity.
Orphenadrine, an analog of diphenydramine, is a skeletal muscle relaxant and is postulated to act on cerebral motor center or on the medulla through an atropine-like central action. It has anticholinergic, local anaesthetic effects and some antihistaminic effects. Orphenadrine is used either as the hydrochloride or the citrate and doses are expressed in terms of the relevant salt.
Pharmacokinetics: Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 minutes to 60 minutes after ingestion. It is metabolized in the liver and excreted in the urine. Less than 5% is excreted as unchanged Paracetamol. Elimination half-life varies from about 1 to 3 hours.
Orphenadrine Citrate is readily absorbed from the gastrointestinal tract. It is rapidly distributed in tissue and most of the dose is metabolized and excreted in the urine along with a small proportion of unchanged drug. A half-life of 14 hours has been reported.

Tension headache, occipital headaches associated with spasm of skeletal muscles in the region of the head and neck. Acute and traumatic conditions of the limbs and trunk: sprains, strains, whiplash injuries, acute torticollis, prolapsed intervertebral disc.

2 tablets 3 times daily.
Mode of Administration: Oral Administration. May be taken with or without food. May be taken with meals if GI discomfort occurs.

Symptoms: Symptoms of orphenadrine overdosage are excitement, confusion, delirium leading to coma. Convulsions and tachycardia with dilated pupils and urinary retention may occur. Paracetamol overdosage may cause acute liver damage, but symptoms may not appear for up to several days after ingestion.
Treatment: Gastric lavage should be carried out immediately regardless of the estimated ingested dose. Convulsions and delirium respond to relatively large doses of diazepam, preferably by mouth. Adequate hydration of the patient is important. It is recommended that the patient be referred to a hospital where early and regular monitoring of plasma paracetamol levels can be carried out. If instituted sufficiently early, treatment with N-acetylcysteine, L-methionine or L-cysteamine will minimize liver damage.

Orphenadrine shows some anticholinergic activity and should not be used in patients with glaucoma, prostatic hypertrophy or obstruction at the bladder neck, or myasthenia gravis.

This preparation contains PARACETAMOL.
Do not take any other paracetamol containing medicine at the same time.

Orphenadrine Citrate should be used with caution in patients with tachycardia, cardiac decompensation, coronary insufficiency or cardiac arrhythmia.
Safety or continuous long-term therapy with orphenadrine has not been established. Therefore, if orphenadrine is prescribed for prolonged use, periodic monitoring of blood, urine and liver function is recommended.
Allergy alert: Paracetamol may cause severe skin reactions. Symptoms may include skin reddening, blisters or rash. These could be signs of serious condition. If these reactions occur, stop use and seek medical assistance right away.
Effect on ability to drive or operate machinery: Orphenadrine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore be cautioned accordingly.

Use in pregnancy: Safe use in pregnancy has not been established; therefore the drug should not be used in pregnant women or those likely to become pregnant unless the expected benefits outweigh the potential risks.
Use in lactation: It is unknown whether orphenadrine is excreted during lactation. However it is established that paracetamol is excreted into the breast milk, one to two hours after oral administration.

Side effects of paracetamol rare and usually mild, although haematological reactions have been reported. Skin rashes and other hypersensitivity reactions occur occasionally.
Paracetamol may cause cutaneous hypersensitivity reactions including skin rashes, angioedema, Stevens Johnson Syndrome / Toxic Epidermal Necrolysis have been reported.
Side effects of orphenadrine citrate include dryness of mouth, tachycardia, palpitation, urinary hesitancy or retention, blurred vision, dilation of the pupils, increased ocular tension, weakness, nausea, headache, dizziness, constipation and drowsiness. These effects can usually be eliminated by reducing the dose.
Sedation, skin rashes and other allergic reactions are very uncommon adverse effects. Infrequently an elderly patient may experience some degree of mental confusion. Very rare cases of aplastic anaemia associated with the use of orphenadrine have been reported.

The effects of antimuscarinic agents such as orphenadrine maybe enhanced by other drugs with antimuscarinic properties such as amantadine, some antihistamines, butyrophenones and phenothiazines, and tricyclic antidepressants. The reduction in gastric motility caused by antimuscarinic agents may affect the absorption of other drugs.

Store at temperature below 30°C. Protect from light and moisture.
Shelf-Life: 3 years.

Muscle Relaxants

M03BC51 - orphenadrine, combinations ; Belongs to the class of ethers. Used as centrally-acting muscle relaxants.

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