Name: M-FACT Side effects, Contraindications
Creator: ndrugs.com
Published: 2021-11-14T10:10:10+00:00

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What are the possible side effects of M-FACT?

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild burning, dryness, or stinging at the application site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, or peeling not present before you began using M-FACT cream; excessive hair growth; inflamed hair follicles; inflammation around the mouth; thinning, softening, or discoloration of the skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the.

Side effects of M-FACT in details

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Allergic Rhinitis

Adults and adolescents 12 years of age and older

In controlled US and international clinical studies, a total of 3210 adult and adolescent patients 12 years and older with allergic rhinitis received treatment with M-FACT nasal spray 50 mcg at doses of 50 to 800 mcg/day. The majority of patients (n = 2103) were treated with 200 mcg/day. A total of 350 adult and adolescent patients have been treated for one year or longer. Adverse events did not differ significantly based on age, sex, or race. Four percent or less of patients in clinical trials discontinued treatment because of adverse events and the discontinuation rate was similar for the vehicle and active comparators.

All adverse events (regardless of relationship to treatment) reported by 5% or more of adult and adolescent patients ages 12 years and older who received M-FACT nasal spray 50 mcg, 200 mcg/day vs. placebo and that were more common with M-FACT nasal spray 50 mcg than placebo, are displayed in TABLE 1 below.

TABLE 1: ADULT AND ADOLESCENT PATIENTS 12 YEARS AND OLDER – ADVERSE EVENTS FROM CONTROLLED CLINICAL TRIALS IN SEASONAL ALLERGIC AND PERENNIAL ALLERGIC RHINITIS (PERCENT OF PATIENTS REPORTING)
	M-FACT Nasal Spray 200 mcg (n = 2103)	Vehicle Placebo (n = 1671)
Headache	26	22
Viral Infection	14	11
Pharyngitis	12	10
Epistaxis/Blood-Tinged Mucus	11	6
Coughing	7	6
Upper Respiratory Tract Infection	6	2
Dysmenorrhea	5	3
Musculoskeletal Pain	5	3
Sinusitis	5	3

Other adverse events which occurred in less than 5% but greater than or equal to 2% of adult and adolescent patients (ages 12 years and older) treated with M-FACT nasal spray 50 mcg, 200-mcg/day (regardless of relationship to treatment), and more frequently than in the placebo group included: arthralgia, asthma, bronchitis, chest pain, conjunctivitis, diarrhea, dyspepsia, earache, flu-like symptoms, myalgia, nausea, and rhinitis.

Pediatric patients <12 years of age

In controlled US and international studies, a total of 990 pediatric patients (ages 3 to 11 years) with allergic rhinitis received treatment with M-FACT nasal spray 50 mcg, at doses of 25 to 200 mcg/day. The majority of pediatric patients (n = 720) were treated with 100 mcg/day. A total of 163 pediatric patients have been treated for one year or longer. Two percent or less of patients in clinical trials who received M-FACT nasal spray 50 mcg discontinued treatment because of adverse events and the discontinuation rate was similar for the placebo and active comparators.

Adverse events which occurred in ≥5% of pediatric patients (ages 3 to 11 years) treated with M-FACT nasal spray 50 mcg, 100 mcg/day vs. placebo (regardless of relationship to treatment) and more frequently than in the placebo group included upper respiratory tract infection (5% in M-FACT nasal spray 50 mcg group vs. 4% in placebo) and vomiting (5% in M-FACT nasal spray 50 mcg group vs. 4% in placebo).

Other adverse events which occurred in less than 5% but greater than or equal to 2% of pediatric patients (ages 3 to 11 years) treated with M-FACT nasal spray 50 mcg, 100 mcg/day vs. placebo (regardless of relationship to treatment) and more frequently than in the placebo group included: diarrhea, nasal irritation, otitis media, and wheezing.

The adverse event (regardless of relationship to treatment) reported by 5% of pediatric patients ages 2 to 5 years who received M-FACT nasal spray, 50 mcg, 100 mcg/day in a clinical trial vs. placebo including 56 subjects (28 each M-FACT nasal spray, 50 mcg and placebo) and that was more common with M-FACT nasal spray, 50 mcg than placebo, included: upper respiratory tract infection (7% vs. 0%, respectively). The other adverse event which occurred in less than 5% but greater than or equal to 2% of M-FACT pediatric patients ages 2 to 5 years treated with 100 mcg doses vs. placebo (regardless of relationship to treatment) and more frequently than in the placebo group included: skin trauma.

Nasal Polyps

Adults 18 years of age and older

In controlled clinical studies, the types of adverse events observed in patients with nasal polyps were similar to those observed for patients with allergic rhinitis. A total of 594 adult patients (ages 18 to 86 years) received M-FACT nasal spray 50 mcg at doses of 200 mcg once or twice daily for up to 4 months for treatment of nasal polyps. The overall incidence of adverse events for patients treated with M-FACT nasal spray 50 mcg was comparable to patients with the placebo except for epistaxis, which was 9% for 200 mcg once daily, 13% for 200 mcg twice daily, and 5% for the placebo.

Nasal ulcers and nasal and oral candidiasis were also reported in patients treated with M-FACT nasal spray 50 mcg primarily in patients treated for longer than 4 weeks.

Nasal Congestion Associated with Seasonal Allergic Rhinitis

A total of 1008 patients aged 12 years and older received M-FACT nasal spray 50 mcg 200 mcg/day (n = 506) or placebo (n = 502) for 15 days. Adverse events that occurred more frequently in patients treated with M-FACT nasal spray 50 mcg than in patients with the placebo included sinus headache (1.2% in M-FACT nasal spray 50 mcg group vs. 0.2% in placebo) and epistaxis (1% in M-FACT nasal spray 50 mcg group vs. 0.2% in placebo) and the overall adverse event profile was similar to that observed in the other allergic rhinitis trials.

Post-Marketing Experience

The following adverse reactions have been identified during the post-marketing period for M-FACT nasal spray 50 mcg: nasal burning and irritation, anaphylaxis and angioedema, disturbances in taste and smell and nasal septal perforation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

What is the most important information I should know about M-FACT?

M-FACT lotion is for external use only. Avoid contact with the eyes.
Do not use M-FACT lotion on the face, underarms, groin, or diaper area unless your doctor tells you to.
If your symptoms do not get better within a few days, or if they get worse, check with your doctor.
Do not use M-FACT lotion for longer than prescribed.
Use M-FACT lotion only for the skin problem that it is intended for. Do not use M-FACT lotion for other skin conditions at a later time.
Do not bandage or cover the treated area unless your doctor tells you to.
M-FACT lotion has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.
Caution is advised when using M-FACT lotion in CHILDREN; they may be more sensitive to its effects. M-FACT lotion should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed. Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use M-FACT lotion.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using M-FACT lotion while you are pregnant. It is not known if M-FACT lotion is found in breast milk. If you are or will be breast-feeding while you use M-FACT lotion, check with your doctor. Discuss any possible risks to your baby.

M-FACT contraindications

References

DailyMed. "FORMOTEROL FUMARATE; MOMETASONE FUROATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
DTP/NCI. "Nasonex: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
European Chemicals Agency - ECHA. "9,21-Dichlor-17-(2-furoyloxy)-11 beta-hydroxy -16 alpha-methylpregna-1,4-dien-3,20-dion: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

M-FACT Side effects