ORPHENADRINE CITRATE 100 mg/1
ORPHENADRINE CITRATE · TABLET, EXTENDED RELEASE · Lupin Pharmaceuticals, Inc.
ORPHENADRINE CITRATE is a tablet, extended release containing orphenadrine citrate at 100 mg/1, taken oral. Manufactured by Lupin Pharmaceuticals, Inc..
Key Facts
- Brand Name
- ORPHENADRINE CITRATE
- Generic Name
- ORPHENADRINE CITRATE
- NDC Code (Product)
43386-480- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Strength
- 100 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA040284
- Marketing Start
- 06/19/1998
Recall History
Sandoz, Inc
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Sandoz Inc
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Attix Pharmaceuticals
Penicillin 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 potential for cross contamination with penicillin.
Aidapak Services, LLC
Labeling: Label Mixup; ORPHENADRINE CITRATE ER Tablet, 100 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W002965, EXP: 6/10/2014.
Premier Pharmacy Labs Inc
Lack 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.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION Adults Two tablets per day; one in the morning and one in the evening.
Warnings
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.
Contraindications
CONTRAINDICATIONS 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.
Adverse Reactions
ADVERSE REACTIONS 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. These adverse reactions can usually be eliminated by reduction in dosage. Very rare cases of aplastic anemia associated with the use of orphenadrine tablets have been reported. No causal relationship has been established.
Frequently Asked Questions
What is ORPHENADRINE CITRATE used for?
ORPHENADRINE CITRATE contains ORPHENADRINE CITRATE. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is ORPHENADRINE CITRATE a controlled substance?
ORPHENADRINE CITRATE is not classified as a controlled substance by the DEA.
What is the generic name for ORPHENADRINE CITRATE?
The generic name for ORPHENADRINE CITRATE is ORPHENADRINE CITRATE. There are 8 other brand versions of ORPHENADRINE CITRATE.
What is the NDC code for ORPHENADRINE CITRATE 100 mg/1?
The NDC (National Drug Code) for ORPHENADRINE CITRATE 100 mg/1 is 43386-480, listed by Lupin Pharmaceuticals, Inc..