Orfro

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of orphenadrine in the pediatric population. Safety and efficacy have not been established .

Geriatric

No information is available on the relationship of age to the effects of orphenadrine in geriatric patients. However, elderly patients are more likely to have age-related heart, liver, or kidney problems which may require caution in patients receiving orphenadrine .

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Bromazepam
• Buprenorphine
• Butorphanol
• Codeine
• Dihydrocodeine
• Donepezil
• Doxylamine
• Fentanyl
• Flibanserin
• Hydrocodone
• Hydromorphone
• Levorphanol
• Meperidine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Oxycodone
• Oxymorphone
• Pentazocine
• Remifentanil
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Tiotropium
• Tramadol
• Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Perphenazine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Enlarged esophagus or
• Enlarged prostate or
• Glaucoma or
• Intestinal blockage or
• Myasthenia gravis or
• Stomach ulcer or
• Urinary tract blockage—Orphenadrine should not be used in patients with these conditions .

• Heart problems (e.g., fast or irregular heartbeats, heart failure)—Use with caution. Orphenadrine may worsen these conditions .

Applies to orphenadrine: compounding powder, injectable solution, oral tablet extended release

Nervous system

Nervous system side effects have included headache, light-headedness, dizziness, drowsiness, syncope and tremor. Infrequently, elderly patients have experienced mental confusion.[Ref]

Ocular

Ocular side effects have included blurred vision, dilatation of pupils, and increased ocular tension.[Ref]

Cardiovascular

Cardiovascular side effects have included tachycardia and palpitations.[Ref]

Genitourinary

Genitourinary side effects have included urinary hesitancy and retention.[Ref]

Gastrointestinal

Gastrointestinal side effects have included dry mouth, nausea, vomiting, and gastric irritation.[Ref]

Musculoskeletal

Musculoskeletal side effects have included weakness.[Ref]

Dermatologic

Dermatologic side effects have included pruritus, and rarely, urticaria and other dermatosis.[Ref]

Psychiatric

Psychiatric side effects have included hallucinations and agitation.[Ref]

Hematologic

Hematologic side effects have included very rare cases of aplastic anemia, however, no causal relationship has been established.[Ref]

Some side effects of Orfro may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.