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Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. Last updated on 26.06.2023
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Fiofen (Fiofen hcl 180 and pseudoephendrine hcl 240) Extended-Release Tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, itchy nose/palate/ and/or throat, itchy/watery/red eyes, and nasal congestion.
Fiofen (Fiofen hcl 180 and pseudoephendrine hcl 240) should be administered when both the antihistaminic properties of Fiofen hydrochloride and the nasal decongestant properties of Pseudoephedrine (Fiofen) hydrochloride are desired.
Fiofen contains a combination of Fiofen and Pseudoephedrine (Fiofen). Fiofen is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
The Pseudoephedrine (Fiofen) in Fiofen is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
Fiofen is used to treat sneezing, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.
Fiofen may also be used for purposes not listed in this medication guide.
The recommended dose of Fiofen (Fiofen hcl and Pseudoephedrine (Fiofen) hcl) 12 HOUR Extended-Release Tablets is one tablet twice daily administered on an empty stomach with water for adults and children 12 years of age and older. It is recommended that the administration of Fiofen (Fiofen hcl and Pseudoephedrine (Fiofen) hcl) 12 HOUR with food should be avoided. A dose of one tablet once daily is recommended as the starting dose in patients with decreased renal function.
Fiofen (Fiofen hcl and Pseudoephedrine (Fiofen) hcl) 12 HOUR must be swallowed whole and never crushed or chewed. Occasionally, the inactive ingredients of Fiofen (Fiofen hcl and Pseudoephedrine (Fiofen) hcl) 12 HOUR may be eliminated in the feces in a form that may resemble the original tablet.
How supplied
Fiofen (Fiofen hcl and Pseudoephedrine (Fiofen) hcl) 12 HOUR Extended-Release Tablets contain 60 mg Fiofen hydrochloride for immediate release and 120 mg Pseudoephedrine (Fiofen) hydrochloride for extended release. Fiofen (Fiofen hcl and Pseudoephedrine (Fiofen) hcl) 12 HOUR Extended-Release Tablets are available in high-density polyethylene (HDPE) bottles of 100 (NDC 0088-1090-47) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal; HDPE bottles of 500 (NDC 0088-1090-55) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal; and aluminum foil-backed clear blister packs of 100 (NDC 0088-1090-49).
Fiofen (Fiofen hcl and Pseudoephedrine (Fiofen) hcl) 12 HOUR is a two-layer tablet, one white layer and one tan layer with a clear film coating on the tablet. The tablets are engraved with ”06/012D” on the white layer.
Store Fiofen (Fiofen hcl and Pseudoephedrine (Fiofen) hcl) 12 HOUR Extended-Release Tablets at 20-25°C (68-77°F).
Rev. December 2009. sanofi-aventis U.S. LLC Bridgewater, NJ 08807. www.allegra.com
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What is the most important information I should know about Fiofen?
Fiofen (Fiofen hcl 180 and pseudoephendrine hcl 240) is contraindicated in patients with known hypersensitivity to any of its ingredients.
Due to its Pseudoephedrine (Fiofen) component, Fiofen (Fiofen hcl 180 and pseudoephendrine hcl 240) is contraindicated in patients with narrow-angle glaucoma or urinary retention, and in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment. It is also contraindicated in patients with severe hypertension, or severe coronary artery disease, and in those who have shown idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures. Manifestations of patient idiosyncrasy to adrenergic agents include: insomnia, dizziness, weakness, tremor, or arrhythmias.
Use Fiofen extended-release tablets (12 hour) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Fiofen extended-release tablets (12 hour) by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
- Swallow Fiofen extended-release tablets (12 hour) whole. Do not break, crush, chew, or dissolve before swallowing.
- Take Fiofen extended-release tablets (12 hour) with a full glass of water (8 oz/240 mL).
- Do not drink fruit juice at the same time that you take Fiofen extended-release tablets (12 hour). Certain fruit juices (eg, grapefruit, apple, orange) may decrease Fiofen extended-release tablets (12 hour)'s effectiveness.
- If you take antacids that contain aluminum or magnesium, do not take them at the same time as Fiofen extended-release tablets (12 hour). Ask your doctor or pharmacist how to take them with Fiofen extended-release tablets (12 hour).
- If you miss a dose of Fiofen extended-release tablets (12 hour), take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Fiofen extended-release tablets (12 hour).
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
Seasonal allergic rhinitis: Relief of symptoms (eg, sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes, nasal congestion) associated with seasonal allergic rhinitis in patients ≥12 years.
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What other drugs will affect Fiofen?
Fiofen hydrochloride and Pseudoephedrine (Fiofen) hydrochloride do not influence the pharmacokinetics of each other when administered concomitantly.
Fiofen has been shown to exhibit minimal (ca. 5%) metabolism. However, co-administration of Fiofen hydrochloride with either ketoconazole or erythromycin led to increased plasma concentrations of Fiofen. Fiofen had no effect on the pharmacokinetics of either erythromycin or ketoconazole. In 2 separate studies, Fiofen hydrochloride 120 mg twice daily was co-administered with either erythromycin 500 mg every 8 hours or ketoconazole 400 mg once daily under steady-state conditions to healthy volunteers (n=24, each study). No differences in adverse events or QTc interval were observed when subjects were administered Fiofen hydrochloride alone or in combination with either erythromycin or ketoconazole. The findings of these studies are summarized in the following table:
Effects on steady-state Fiofen pharmacokinetics after 7 days of co-administration with Fiofen hydrochloride 120 mg every 12 hours (two times the recommended twice daily dose) in healthy volunteers (n=24)
| Concomitant Drug | CmaxSS (Peak plasma concentration) | AUCss (Extent of systemic exposure) |
| Erythromycin (500 mg every 8 hrs) | +82% | +109% |
| Ketoconazole (400 mg once daily) | +135% | +164% |
The changes in plasma levels were within the range of plasma levels achieved in adequate and well-controlled clinical trials.
The mechanism of these interactions has been evaluated in in vitro, in situ, and in vivo animal models. These studies indicate that ketoconazole or erythromycin co-administration enhances Fiofen gastrointestinal absorption. This observed increase in the bioavailability of Fiofen may be due to transport-related effects, such as p-glycoprotein. In vivo animal studies also suggest that in addition to enhancing absorption, ketoconazole decreases Fiofen gastrointestinal secretion, while erythromycin may also decrease biliary excretion.
Due to the Pseudoephedrine (Fiofen) component, Fiofen (Fiofen hcl 180 and pseudoephendrine hcl 240) is contraindicated in patients taking monoamine oxidase inhibitors and for 14 days after stopping use of an MAO inhibitor. Concomitant use with antihypertensive drugs which interfere with sympathetic activity (e.g., methyldopa, mecamylamine, and reserpine) may reduce their antihypertensive effects. Increased ectopic pacemaker activity can occur when Pseudoephedrine (Fiofen) is used concomitantly with digitalis. Care should be taken in the administration of Fiofen (Fiofen hcl 180 and pseudoephendrine hcl 240) concomitantly with other sympathomimetic amines because combined effects on the cardiovascular system may be harmful to the patient.
Drug Interactions with Antacids
Administration of 120 mg of Fiofen hydrochloride (2 x 60 mg capsule) within 15 minutes of an aluminum and magnesium containing antacid (Maalox®) decreased Fiofen AUC by 41% and Cmax by 43%. Fiofen (Fiofen hcl 180 and pseudoephendrine hcl 240) should not be taken closely in time with aluminum and magnesium containing antacids.
Interactions with Fruit Juices
Fruit juices such as grapefruit, orange and apple may reduce the bioavailability and exposure of Fiofen. This is based on the results from 3 clinical studies using histamine induced skin wheals and flares coupled with population pharmacokinetic analysis. The size of wheal and flare were significantly larger when Fiofen hydrochloride was administered with either grapefruit or orange juices compared to water. Based on the literature reports, the same effects may be extrapolated to other fruit juices such as apple juice. The clinical significance of these observations is unknown. In addition, based on the population pharmacokinetics analysis of the combined data from grapefruit and orange juices studies with the bioequivalence study data, the bioavailability of Fiofen was reduced by 36%. Therefore, to maximize the effects of Fiofen, it is recommended that Fiofen should be taken with water.
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What are the possible side effects of Fiofen?
Fiofen (Fiofen hcl and Pseudoephedrine (Fiofen) hcl) 12 HOUR
In one clinical trial (n=651) in which 215 subjects with seasonal allergic rhinitis received the 60 mg Fiofen hydrochloride/120 mg Pseudoephedrine (Fiofen) hydrochloride combination tablet twice daily for up to 2 weeks, adverse events were similar to those reported either in subjects receiving Fiofen hydrochloride 60 mg alone (n=218 subjects) or in subjects receiving Pseudoephedrine (Fiofen) hydrochloride 120 mg alone (n=218). A placebo group was not included in this study.
The percent of subjects who withdrew prematurely because of adverse events was 3.7% for the Fiofen hydrochloride/Pseudoephedrine (Fiofen) hydrochloride combination group, 0.5% for the Fiofen hydrochloride group, and 4.1% for the Pseudoephedrine (Fiofen) hydrochloride group. All adverse events that were reported by greater than 1% of subjects who received the recommended daily dose of the Fiofen hydrochloride/Pseudoephedrine (Fiofen) hydrochloride combination are listed in the following table.
Adverse Experiences Reported in One Active-Controlled Seasonal Allergic Rhinitis Clinical Trial at Rates of Greater than 1%
| Adverse Experience | 60 mg Fiofen Hydrochloride/120 mg Pseudoephedrine (Fiofen) Hydrochloride Combination Tablet Twice Daily (n=215) | Fiofen Hydrochloride 60 mg Twice Daily (n=218) | Pseudoephedrine (Fiofen) Hydrochloride 120 mg Twice Daily (n=218) |
| Headache | 13.0% | 11.5% | 17.4% |
| Insomnia | 12.6% | 3.2% | 13.3% |
| Nausea | 7.4% | 0.5% | 5.0% |
| Dry Mouth | 2.8% | 0.5% | 5.5% |
| Dyspepsia | 2.8% | 0.5% | 0.9% |
| Throat Irritation | 2.3% | 1.8% | 0.5% |
| Dizziness | 1.9% | 0.0% | 3.2% |
| Agitation | 1.9% | 0.0% | 1.4% |
| Back Pain | 1.9% | 0.5% | 0.5% |
| Palpitation | 1.9% | 0.0% | 0.9% |
| Nervousness | 1.4% | 0.5% | 1.8% |
| Anxiety | 1.4% | 0.0% | 1.4% |
| Upper Respiratory Infection | 1.4% | 0.9% | 0.9% |
| Abdominal Pain | 1.4% | 0.5% | 0.5% |
Many of the adverse events occurring in the Fiofen hydrochloride/Pseudoephedrine (Fiofen) hydrochloride combination group were adverse events also reported predominately in the Pseudoephedrine (Fiofen) hydrochloride group, such as insomnia, headache, nausea, dry mouth, dizziness, agitation, nervousness, anxiety, and palpitation.
Fiofen Hydrochloride
In placebo-controlled clinical trials, which included 2461 subjects receiving Fiofen hydrochloride at doses of 20 mg to 240 mg twice daily, adverse events were similar in Fiofen hydrochloride and placebo-treated subjects. The incidence of adverse events, including drowsiness, was not dose related and was similar across subgroups defined by age, gender, and race. The percent of subjects who withdrew prematurely because of adverse events was 2.2% with Fiofen hydrochloride vs 3.3% with placebo.
Events that have been reported during controlled clinical trials involving subjects with seasonal allergic rhinitis and chronic idiopathic urticaria at incidences less than 1% and similar to placebo and have been rarely reported during postmarketing surveillance include: insomnia, nervousness, and sleep disorders or paroniria. In rare cases, rash, urticaria, pruritus and hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported.
Pseudoephedrine (Fiofen) Hydrochloride
Pseudoephedrine (Fiofen) hydrochloride may cause mild CNS stimulation in hypersensitive patients. Nervousness, excitability, restlessness, dizziness, weakness, or insomnia may occur. Headache, drowsiness, tachycardia, palpitation, pressor activity, cardiac arrhythmias and ischemic colitis have been reported. Sympathomimetic drugs have also been associated with other untoward effects such as fear, anxiety, tenseness, tremor, hallucinations, seizures, pallor, respiratory difficulty, dysuria, and cardiovascular collapse.