Rebreath 175 mg/3 ml

Description

Indications
Rebreath is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). It helps manage COPD symptoms and improve lung function over time.
Take the medicine according to the advice of a registered physician.

Pharmacology
Revefenacin is a long-acting muscarinic antagonist, commonly referred to as an anticholinergic. It has a similar affinity for the subtypes of muscarinic receptors M1 to M5. In the airways, it works by inhibiting the M3 receptor in smooth muscle, leading to bronchodilation. The antagonistic effect is competitive and reversible, as demonstrated in studies using human and animal receptors and isolated organ preparations. Preclinical studies, both in vitro and in vivo, show that Revefenacin prevents methacholine- and acetylcholine-induced bronchoconstriction in a dose-dependent manner, with effects lasting more than 24 hours. The clinical significance of these findings is not fully established. The bronchodilation from inhalation of Revefenacin is primarily localized in the airways.

Dosage & Administration
The recommended dosage is 175 mcg of Revefenacin (one 175 mcg unit-dose vial) administered once daily by oral inhalation through a nebulizer using a mouthpiece.

Revefenacin should be used only via oral inhalation with a standard jet nebulizer connected to an air compressor. The safety and efficacy of Revefenacin when delivered through non-compressor-based nebulizer systems have not been established. The unit-dose vial should be removed from the foil pouch and opened immediately before use. Any remaining contents should be discarded after use.

No dosage adjustment is required for elderly patients or those with renal impairment.

The drug compatibility (physical and chemical), efficacy, and safety of Revefenacin when mixed with other drugs in a nebulizer have not been established.
Take the medicine according to the advice of a registered physician.

Interaction

• Anticholinergics: There is a potential for additive interactions with other anticholinergic medicines. Therefore, concomitant use of Rebreath with other anticholinergic drugs should be avoided, as it may increase the risk of anticholinergic side effects.
• Transporter-Related Drug Interactions: Inhibitors of OATP1B1 and OATP1B3 (such as rifampicin and cyclosporine) could increase systemic exposure to the active metabolite of Revefenacin. Therefore, coadministration with such drugs is not recommended.

Contraindications
Revefenacin is contraindicated in patients with known hypersensitivity to Revefenacin or any component of this product.

Side Effects
Common side effects of Rebreath may include:

• Cough
• Runny nose
• Upper respiratory tract infection
• Headache
• Back pain

Pregnancy & Lactation
There are no adequate and well-controlled studies of Revefenacin in pregnant women. Women should consult their physician if they become pregnant while taking this medication. In animal studies, subcutaneous administration of Revefenacin to pregnant rats and rabbits during organ development showed no fetal harm at exposures approximately 209 times the maximum recommended human dose (MRHD).

There is no data on the presence of Revefenacin in human breast milk, its effects on the breastfed infant, or its impact on milk production. However, animal studies indicate that Revefenacin is present in the milk of lactating rats. The benefits of breastfeeding should be weighed against the mother’s clinical need for Revefenacin and any potential adverse effects on the infant.

Precautions & Warnings

• Deterioration of Disease & Acute Episodes: Rebreath should not be started during an acute or life-threatening episode of COPD. It is intended for long-term maintenance and should not be used for rapid relief of symptoms. Patients experiencing worsening COPD symptoms should seek immediate medical attention.
• Paradoxical Bronchospasm: Like other inhaled medications, Rebreath may cause paradoxical bronchospasm, which can be life-threatening. If this occurs, discontinue use immediately and treat with a short-acting bronchodilator.
• Narrow-Angle Glaucoma: Use with caution in patients with narrow-angle glaucoma. Symptoms such as eye pain, blurred vision, visual halos, and redness should be reported immediately to a physician.
• Urinary Retention: Patients with prostatic hyperplasia or bladder-neck obstruction should use Rebreath cautiously, as it may worsen urinary retention. Symptoms such as difficulty urinating or painful urination should be reported to a healthcare provider.
• Immediate Hypersensitivity Reactions: If an allergic reaction occurs, discontinue the medication immediately and seek alternative treatment.

Use in Special Populations

• Pediatric Use: The safety and efficacy of Rebreath have not been established in children, and it is not recommended for pediatric patients.
• Geriatric Use: No dosage adjustment is necessary for elderly patients.
• Hepatic Impairment: Patients with moderate hepatic impairment may experience increased exposure to the active metabolite. The safety of Rebreath in patients with mild to severe hepatic impairment has not been established; its use is not recommended in such cases.
• Renal Impairment: No dosage adjustment is required. However, patients with severe renal impairment should be monitored for systemic antimuscarinic side effects.

Therapeutic Class
Anticholinergic bronchodilators

Storage Conditions
Store at room temperature (20°C to 25°C). Protect from direct sunlight and excessive heat. Keep out of reach of children.