Pricing
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All price changes →Aclitol
Rx400 mcg+12 mcg • Dry Powder Inhalation Capsule (DPI)
Indications & Uses
Aclidinium Bromide + Formoterol Fumarate is used as maintenance treatment for patients with chronic obstructive pulmonary disease (COPD).
Pharmacology
Aclidinium bromide is a long-acting anti-muscarinic agent, often called an anticholinergic. It has a similar affinity for the muscarinic receptor subtypes M1 to M5. In the airways, it works by blocking M3 receptors on the smooth muscle, and this leads to bronchodilation. Studies on human and animal receptors and on isolated organ preparations showed that the blocking is competitive and reversible. In preclinical in vitro and in vivo studies, aclidinium bromide prevented acetylcholine-induced bronchoconstriction in a dose-dependent way, and the effect lasted longer than 24 hours. The clinical relevance of these findings is unknown. After inhalation, the bronchodilation is mainly a site-specific effect.
Formoterol fumarate is a long-acting selective beta2-adrenergic receptor agonist (LABA), also called a beta 2-agonist. When inhaled, it acts locally in the lung as a bronchodilator. The effects of beta 2-adrenoceptor agonist drugs, formoterol included, are at least in part due to stimulation of intracellular adenyl cyclase. This is the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3', 5'-adenosine monophosphate (cyclic AMP). Higher cyclic AMP levels relax the bronchial smooth muscle. They also reduce the release of mediators of immediate hypersensitivity from cells, especially from mast cells.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Aclidinium Bromide + Formoterol Fumarate is for oral inhalation only, and you take it through an inhaler device. The dose is 400 mcg/12 mcg twice daily, which means one inhalation capsule in the morning and one in the evening. Don't take more than one inhalation twice daily.
Side Effects
The most common side effects with Aclidinium Bromide + Formoterol Fumarate are upper respiratory tract infection and headache. They occurred in 3% of people or more, and more often than with placebo.
Cautions & Contraindications
Warnings & Precautions
Asthma-related death: when long-acting beta2-adrenergic agonists are used alone for asthma (without an inhaled corticosteroid), the risk of serious asthma-related events goes up. Don't start Aclidinium Bromide + Formoterol Fumarate in acutely deteriorating COPD, and don't use it to treat acute symptoms. It should not be taken together with any other medicine that contains a LABA, because of the risk of overdose. If paradoxical bronchospasm occurs, stop Aclidinium Bromide + Formoterol Fumarate and start alternative therapy. Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus and ketoacidosis. Be alert to hypokalemia and hyperglycemia. Use with caution in patients with narrow-angle glaucoma, and tell them to contact a doctor immediately if symptoms occur. Worsening urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction, and tell them to consult a doctor immediately if symptoms occur.
Contraindications
Aclidinium bromide and formoterol fumarate should not be given to patients with asthma if a long-acting beta 2-adrenergic agonist (LABA) is used without an inhaled corticosteroid. Formoterol fumarate, one of the two active ingredients in this combination, is a LABA, so this applies to it. The medicine must also not be used by anyone who is hypersensitive to aclidinium bromide or formoterol fumarate, or to any other component of the product.
Pregnancy & Breastfeeding
There aren't any adequate, well-controlled studies of Aclidinium Bromide + Formoterol Fumarate in pregnant women, so the risks linked to the medicine aren't known. The same is true for its two components, aclidinium bromide and formoterol fumarate, when each is studied on its own. There are also no data on how aclidinium bromide or formoterol fumarate affect a breastfed child or milk production, or whether either one passes into human milk.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Common questions about Aclitol 400 mcg+12 mcg
What is Aclitol 400 mcg+12 mcg Dry Powder Inhalation Capsule (DPI)?
Aclitol 400 mcg+12 mcg Dry Powder Inhalation Capsule (DPI) is a medicine that contains Aclidinium Bromide + Formoterol Fumarate. It is made by Square Pharmaceuticals PLC, Pabna. It belongs to the Combined bronchodilators group of medicines.
What is Aclitol used for?
Aclidinium Bromide + Formoterol Fumarate is used as maintenance treatment for patients with chronic obstructive pulmonary disease (COPD).
What are the side effects of Aclitol?
The most common side effects with Aclidinium Bromide + Formoterol Fumarate are upper respiratory tract infection and headache. They occurred in 3% of people or more, and more often than with placebo.
Can I take Aclitol during pregnancy or while breastfeeding?
There aren't any adequate, well-controlled studies of Aclidinium Bromide + Formoterol Fumarate in pregnant women, so the risks linked to the medicine aren't known. The same is true for its two components, aclidinium bromide and formoterol fumarate, when each is studied on its own. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Is there a cheaper medicine with the same ingredient?
Aclitol is already among the lowest-priced brands of Aclidinium Bromide + Formoterol Fumarate at this strength.
Do I need a prescription for Aclitol?
Aclitol is a prescription (Rx) medicine. Take it as your doctor advises.