Canceled South Africa · SAHPRA

TIOTROPIUM ADCO

TIOTROPIUM BROMIDE EQUIVALENT TO TIOTROPIUM

51/10.2.1/1121.120 INN generic

What it does

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

Commonly used for: chronic obstructive pulmonary disease (COPD), asthma

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

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Sourcing - Kenya only

Registration & product details

Registration no.
51/10.2.1/1121.120
Registration date
2021/03/08
Expiry date
-
Status
Canceled
Active ingredient
TIOTROPIUM BROMIDE EQUIVALENT TO TIOTROPIUM
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
Adcock Ingram Limited
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:12:46 · updated 2026-09-16 04:00:08

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 South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

About this medicine

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: 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.