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Orphenadrine

Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort a.

Checked against the official label · Updated

ز - الأدوية التي تصرف بموجب وصفة طبية Oral Safety alerts on record

How to use Orphenadrine

ما تقوله النشرة الرسمية. إذا وصفه لك طبيب، فاتبع الوصفة. وإذا اختلفت نشرة عبوتك، فالأولوية لها.

لمن هو

Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.

كيف يُتناول وكم مرة

Adults Two tablets per day; one in the morning and one in the evening.

Children
  • Safety and effectiveness
  • In pediatric patients have not been established
Talk to a doctor first if
  • Orphenadrine citrate extended-release tablets are contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (mega-esophagus) and myasthenia gravis
  • Orphenadrine citrate tablets are contraindicated in patients who have demonstrated a previous hypersensitivity to the drug
Warnings

Some patients may experience transient episodes of light-headedness, dizziness or syncope. 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.

الآثار الجانبية المحتملة

Adverse reactions of orphenadrine are mainly due to the mild anticholinergic action of orphenadrine, and are usually associated with higher dosage. Dryness of the mouth is usually the first adverse effect to appear. When the daily dose is increased, possible adverse effects include: tachycardia, palpitation, urinary hesitancy or retention, blurred vision, dilatation of pupils, increased ocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, hypersensitivity reactions, pruritus, hallucinations, agitation, tremor, gastric irritation, and rarely urticaria and other dermatoses. Infrequently, an elderly patient may experience some degree of mental confusion. …

Pregnancy and breastfeeding

Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with orphenadrine. It is also not known whether orphenadrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Orphenadrine should be given to a pregnant woman only if clearly needed.

If you take too much

Orphenadrine is toxic when overdosed and typically induces anticholinergic effects. In a review of orphenadrine toxicity, the minimum lethal dose was found to be 2 to 3 grams for adults; however, the range of toxicity is variable and unpredictable. Treatment for orphenadrine overdose is evacuation of stomach contents (when necessary), charcoal at repeated doses, intensive monitoring, and appropriate supportive treatment of any emergent anticholinergic effects.

الاعتماد وإساءة الاستخدام

Orphenadrine has been chronically abused for its euphoric effects. The mood elevating effects may occur at therapeutic doses of orphenadrine.

إذا نسيت جرعة

تناولها عندما تتذكر، إلا إذا اقترب موعد الجرعة التالية. عندها تخطَّ الجرعة المنسية. لا تتناول جرعتين معًا أبدًا للتعويض. راجع النشرة، فبعض الأدوية مختلفة.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2026-01-01.

الأسماء التجارية حول العالم

Products with Orphenadrine as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

Orphenadrine CitrateORPHENADRINE CITRATE 100 mg/1 · Tablet, Extended Release · NuCare Pharmaceuticals, Inc.
NDC 66267-158Label
Orphenadrine CitrateORPHENADRINE CITRATE 100 mg/1 · Tablet, Extended Release · PD-Rx Pharmaceuticals, Inc.
NDC 43063-407Label
Orphenadrine CitrateORPHENADRINE CITRATE 100 mg/1 · Tablet, Extended Release · Lake Erie Medical DBA Quality Care Products LLC
NDC 49999-046Label
Orphenadrine Citrate Er ErORPHENADRINE CITRATE 100 mg/1 · Tablet, Extended Release · Advanced Rx Pharmacy of Tennessee, LLC
NDC 80425-0117Label
Orphenadrine CitrateORPHENADRINE CITRATE 100 mg/1 · Tablet, Extended Release · Proficient Rx LP
NDC 63187-632Label

Nigeria (NAFDAC)

NAFDACAnorol Tablet 04-1471NAFDACEpigesic Tablets A4-0008NAFDACNorpiflex Tablet B4-6601NAFDACOrphesic Tablets_ A4-2181NAFDACOrphetab Tablet 100 mg A4-4162

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.U.S. FDA Class II
21 Mar 2022 · Sandoz, Inc · TerminatedCGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FLU.S. FDA Class II
18 Jun 2019 · Premier Pharmacy Labs Inc · TerminatedLack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Orphenadrine Citrate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5AU.S. FDA Class II
14 Nov 2014 · Attix Pharmaceuticals · TerminatedPenicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the poten
Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., PrincU.S. FDA Class III
11 Jul 2014 · Sandoz Inc · TerminatedFailed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Orphenadrine

Type the registration number on the pack, or scan it with your camera.

أو التقط صورًا للعبوة
تبقّت 3 عمليات تحقق مجانية اليوم Official sources: U.S. FDA · EMA (EU) · Health Canada · WHO alerts

Questions about Orphenadrine

What is Orphenadrine used for?

Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. (From the official U.S. FDA label.)

How do I take Orphenadrine?

Follow your prescription or the leaflet in your pack. The official label says: Adults Two tablets per day; one in the morning and one in the evening.…

Do I need a prescription for Orphenadrine?

Usually yes. Orphenadrine is a prescription medicine in most countries. Rules differ by country.

What brands contain Orphenadrine?

Orphenadrine is sold under names such as Norgesic, Orphengesic, Orphenadrine Citrate. Brand names differ between countries.

What are the side effects of Orphenadrine?

The official label lists: Adverse reactions of orphenadrine are mainly due to the mild anticholinergic action of orphenadrine, and are usually associated with higher dosage. Dryness of the mouth is usually the first adverse effect to appear. When the daily dose is increased, possible adverse effects include: tachycardia, palpitation, urinary hesitancy or retention, blurred vision, dilatation of pupils… Tell your doctor about any side effect that bothers you or does not go away.

Can children take Orphenadrine?

Safety and effectiveness in pediatric patients have not been established. Always use the dose for the child's age or weight on the pack or prescription.

Can I take Orphenadrine when pregnant or breastfeeding?

Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with orphenadrine. It is also not known whether orphenadrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Orphenadrine should be given to a pregnant woman only if clearly needed. Ask your doctor or midwife first.

What happens if I take too much Orphenadrine?

Orphenadrine is toxic when overdosed and typically induces anticholinergic effects. In a review of orphenadrine toxicity, the minimum lethal dose was found to be 2 to 3 grams for adults; however, the range of toxicity is variable and unpredictable. Treatment for orphenadrine overdose is evacuation o… Get medical help right away.

How can I check that my Orphenadrine is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.

Sources

This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.