Registered Rwanda · Rwanda FDA

SPIRIVA RESPIMAT

Tiotropium bromide monohydrate 2.5 microgram

Rwanda FDA-HMP-MA-0956 Solution for Inhalation 2.5 microgram INN generic

What it does

Microgram is a measurement used in medicine to indicate very small amounts of a substance, usually for precise dosing.

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-0956
Registration date
26/02/2024
Expiry date
25/02/2029
Status
Registered
Active ingredient
Tiotropium bromide monohydrate 2.5 microgram
Strength
2.5 microgram
Pack size
Cartridge/ 60 puffs and 1 Respimat inhaler
Therapeutic class
-
Country of origin
GERMANY
Manufacturer location
Binger Str. 173, 55218 Ingelheim am Rhein, Germany

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:19 · updated 2026-09-21 02:30:20

Drug Interactions

2
Check interactions

Pharmacodynamic Warnings

Tiotropium appears in TABLE 10: Drugs with antimuscarinic effects

Unknown (2)

Tiotropium - additive effect

Clozapine can cause constipation, as can tiotropium; concurrent use might increase the risk of developing intestinal obstruction. Also see TABLE 10 p. 1519

Unknown Theoretical

Tiotropium - additive effect

Antipsychotics, second generation (clozapine) can cause constipation, as can tiotropium; concurrent use might increase the risk of developing intestinal obstruction. Also see TABLE 10 p. 1519 Tipranav

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About microgram

Microgram is a measurement used in medicine to indicate very small amounts of a substance, usually for precise dosing.

How it works

Microgram refers to a unit of measurement, not a specific medication, and is used to ensure accurate dosing of medications.

Who it's for

Microgram measurements are relevant for patients who need specific doses of medications that are measured in very small amounts.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About tiotropium

Tiotropium is a medication used to help open the airways in the lungs, making it easier to breathe.

What it treats

  • chronic obstructive pulmonary disease (COPD)
  • asthma

How it works

It works by relaxing the muscles around the airways, which helps to keep them open.

Who it's for

This medicine is for adults with respiratory conditions like COPD and asthma.

Cautions

  • • Avoid using with other medications that have antimuscarinic effects.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: microgram

Micrograms are a unit of measurement used to quantify dosages of substances, particularly medications. A microgram (µg) is one-millionth of a gram and is commonly used in pharmacology for dosing hormones, vitamins, and other potent drugs where small quantities are effective. The precise measurement in micrograms is crucial for achieving the desired therapeutic effects while minimizing the risk of toxicity.

Dosage

Children: Paediatric dosing in micrograms is also highly variable based on the drug and the condition being treated. Refer to the BNF for Children for detailed dosing recommendations.

Adults: Dosage in micrograms varies widely depending on the specific medication and its indication. Consult relevant clinical guidelines or the BNF for precise dosing information.

Mechanism of action

The mechanism of action varies depending on the specific drug being measured in micrograms. For example, many drugs operate by binding to specific receptors or enzymes, leading to a physiological response. This can include agonistic or antagonistic effects on neurotransmitter systems, modulation of immune responses, or alteration of metabolic pathways.

Pharmacodynamics

Pharmacodynamics refers to the effects of the drug on the body, including the relationship between drug concentration and effect. Drugs measured in micrograms often have a steep dose-response curve, meaning small changes in dosage can lead to significant changes in therapeutic and adverse effects. The potency of such drugs is typically high, necessitating careful dosing and monitoring.

Pharmacokinetics

Pharmacokinetics involves the study of how the body absorbs, distributes, metabolizes, and excretes a drug. Drugs administered in microgram doses may exhibit rapid absorption and distribution, especially if given intravenously or sublingually. Metabolism often occurs in the liver, and excretion can be renal or via bile, depending on the drug's chemical properties. Understanding the pharmacokinetics is essential for optimizing therapeutic regimens and minimizing side effects.

Pregnancy

Consult a healthcare professional before use. Safety and efficacy during pregnancy have not been established.

Breast-feeding

Consult a healthcare professional before use. It is not known if this drug is excreted in human milk.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: Tiotropium

BNF-referenced

Tiotropium is a long-acting antimuscarinic agent used primarily in the management of chronic obstructive pulmonary disease (COPD) and asthma. It acts as a bronchodilator by inhibiting the muscarinic receptors in the airways, thereby reducing bronchoconstriction and improving airflow. Tiotropium is administered via inhalation and offers once-daily dosing, making it a convenient option for patients requiring maintenance therapy.

Indications

  • Maintenance treatment of chronic obstructive pulmonary disease (COPD)
  • Severe asthma as an add-on therapy to inhaled corticosteroids and other controllers

Dosage

Children: For children aged 6-11 years: 5 micrograms once daily. For children aged 12-17 years, refer to BNF for Children for specific dosing guidance.

Adults: 1 capsule (18 micrograms) once daily by inhalation.

Mechanism of action

Tiotropium exerts its effects by selectively blocking the M3 muscarinic acetylcholine receptors in the bronchial smooth muscle. This blockade leads to relaxation of the bronchial muscles and dilation of the airways. The inhibition of these receptors prevents bronchoconstriction and facilitates easier breathing in patients with obstructive pulmonary diseases.

Pharmacodynamics

Tiotropium has a long duration of action due to its slow dissociation from the M3 receptors, allowing for sustained bronchodilation over a 24-hour period. The onset of action typically begins within 30 minutes of administration, with peak effects occurring around 3 hours post-dose. It significantly improves lung function, reduces exacerbation rates, and enhances exercise tolerance in patients with COPD.

Pharmacokinetics

Tiotropium is primarily absorbed through the lungs when inhaled, with approximately 20% of the delivered dose reaching systemic circulation. The drug undergoes minimal hepatic metabolism, primarily via cytochrome P450 enzymes, and is mainly excreted unchanged in the urine. The elimination half-life is approximately 5 to 6 days, which supports its once-daily dosing regimen.

Contra-indications

  • Hypersensitivity to tiotropium, atropine or its derivatives
  • Patients with narrow-angle glaucoma
  • Patients with urinary retention

Adverse effects

  • Cough
  • Dizziness
  • Dry mouth
  • Headache
  • Nausea
  • Constipation
  • Dysphonia
  • Palpitations
  • Skin reactions
  • Stomatitis
  • Urinary disorders
  • Vision blurred

Interactions

  • Clozapine: Unknown (additive effect)
  • Second-generation antipsychotics: Unknown (additive effect)

Precautions

  • Counsel patients on appropriate administration technique
  • Warn against accidental contact with the eye due to risk of ocular complications
  • Increased risk of dizziness affecting driving and skilled tasks

Pregnancy

Manufacturer advises only use if potential benefit outweighs risk.

Breast-feeding

No information available-manufacturer advises only use if potential benefit outweighs risk.

Storage

Store in a cool, dry place, away from direct sunlight.

Formulations

  • {'name': 'Spiriva® Inhalation Powder', 'dose': '18 micrograms per capsule', 'route': 'inhalation'}
  • {'name': 'Braltus® Inhalation Powder', 'dose': '13 micrograms per capsule', 'route': 'inhalation'}
  • {'name': 'Nebuliser liquid', 'dose': 'Variable, refer to specific product information', 'route': 'nebulisation'}
BNF 85 (British National Formulary) p.289 BNF for Children 2019-2020 p.177 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Tiotropium

PubChem CID 5487427

Molecular formula: C19H22NO4S2+

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.