DESCRIPTION Norflex 100 mg:
Orphenadrine citrate citrate salt of orphenadrine (2-dimethylaminoethyl citrate ester). It occurs as white, crystalline powder with a bitter taste. This practically odorless, moderately soluble in water, slightly soluble in alcohol. Each extended-release tablet NORFLEX contains 100 mg of citrate orphenadrine. NORFLEX Extendedrelease The tablets also contain: calcium stearate, ethylcellulose, and lactose. NORFLEX injection contains 60 mg orphenadrine citrate in aqueous solution in each ampoule. NORFLEX injection well contains: sodium bisulfite NF, 2,0 mg of sodium chloride USP, 5,8 mg, sodium hydroxide, to adjust pH and water for injection USP, qs 2 ml.
Clinical pharmacology Norflex 100 mg:
Mode of therapeutic action have not been clearly defined, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense skeletal muscles. Orphenadrine citrate also possesses anti-cholinergic action.
INDICATIONS AND USAGE Norflex 100 mg:
Orphenadrine citrate is indicated as an adjunct to rest, physical therapy and other measures to Relief of discomfort associated with acute painful musculo skeletal conditions.
CONTRAINDICATIONS Norflex 100 mg:
Contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcer ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (megaesophagus) and myasthenia Gravis.
Contraindicated in patients who have demonstrated prior hypersensitivity to the drug.
WARNINGS Norflex 100 mg:
Some patients may experience transient episodes of light-headed or fainting. NORFLEX can disrupt a patient’s ability to engage in potentially hazardous activities such as operating machinery or driving a car, ambulatory patients should be warned accordingly. NORFLEX injection contains sodium bisulfite, sulfite, which can cause allergic reactions such as including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible individuals. The overall prevalence of sulfite sensitivity in the general population unknown and probably low. Sulfite sensitivity is seen more frequently than patients with bronchial asthma nonasthmatic people.
Precautions Norflex 100 mg:
Confusion, anxiety and tremors have been recorded in a few patients receiving propoxyphene and orphenadrine together. Since these symptoms may be simply due to the additive effect, decrease the dosage and / or termination of one or both agents is recommended in such cases. Orphenadrine citrate should be used with caution in patients with tachycardia, cardiac decompensation, coronary insufficiency, cardiac arrhythmias. Safety of continuous long-term therapy with orphenadrine has not been established. Thus, if orphenadrine prescribed for prolonged use, periodic monitoring of blood, urine and liver function values is recommended.
Pregnancy Norflex 100 mg:
Pregnancy Category C. animal reproduction studies are not conducted with NORFLEX. This Also unknown is whether NORFLEX may cause fetal harm when administered pregnant woman or can affect reproduction capacity. NORFLEX should be given to pregnant women only if clearly necessary.
Pediatric Use Norflex 100 mg:
Safety and effectiveness in children have not been established.
SIDE Norflex 100 mg:
Adverse reactions orphenadrine mainly due to the mild anti-cholinergic action orphenadrine, and are usually associated with a higher dosage. Dry mouth, usually the first adverse effect on emerging. If the daily dose increases, the possible side effects include: tachycardia, palpitation, urinary hesitancy or retention, blurred vision, dilated pupils, increased intraocular pressure, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, hypersensitivity reactions, pruritus, hallucinations, agitation, tremors, stomach irritation, and rarely urticaria and other dermatoses. Infrequently, an elderly patient may Experience some degree of confusion. These adverse reactions can usually be eliminated
dose reduction. Very rare cases of aplastic anemia associated with orphenadrine tablets have been reported. No causal link was established. Rare cases of anaphylactic reactions have been reported associated with intramuscular Introduction NORFLEX injections.
Drug Abuse and Dependence
Orphenadrine was chronically abused its euphoric effects. The mood elevating ffects may occur at therapeutic doses of orphenadrine.
OVERDOSAGE Norflex 100 mg
Orphenadrine is toxic in overdose and usually causes anticholinergic effects. In Overview of orphenadrine toxicity, the minimum lethal dose was 2.3 grams for adults; However, the spectrum of toxicity of different and unpredictable. Treatment of orphenadrine overdose evacuation of stomach contents (if necessary), charcoal at repeated doses, intensive monitoring and appropriate supportive treatment to any emerging anticholinergic effects.
