Registered South Africa · SAHPRA

BOTOX

Botulinum Toxin Type A

27/30.4/0164

What it does

Botulinum is a substance used to treat various conditions by blocking nerve signals in muscles.

Commonly used for: muscle stiffness (spasticity), excess sweating (hyperhidrosis), migraines, facial wrinkles

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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.
27/30.4/0164
Registration date
1993/05/02
Expiry date
-
Status
Registered
Active ingredient
Botulinum Toxin Type A
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
Abbvie (Pty) Ltd
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:11:28 · updated 2026-10-21 04:00:08

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 botulinum

Botulinum is a substance used to treat various conditions by blocking nerve signals in muscles.

What it treats

  • muscle stiffness (spasticity)
  • excess sweating (hyperhidrosis)
  • migraines
  • facial wrinkles

How it works

It works by preventing nerves from signaling muscles to contract, which can help reduce muscle activity and improve symptoms.

Who it's for

It is suitable for adults with specific muscle-related conditions or cosmetic concerns.

Cautions

  • • May cause side effects like weakness or difficulty swallowing.
  • • Not recommended for individuals with certain allergies or infections at the injection site.

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

About toxin

Toxin is a harmful substance that can cause various health issues.

What it treats

  • poisoning
  • toxic reactions

How it works

Toxins disrupt normal bodily functions, which can lead to serious health problems.

Who it's for

This information is relevant for anyone who may encounter or be exposed to toxic substances.

Cautions

  • • Handle with care to avoid exposure.
  • • Seek immediate medical attention if ingested or inhaled.

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

Clinical monograph: botulinum

Botulinum toxin, produced by the bacterium Clostridium botulinum, is a potent neurotoxin that inhibits neurotransmitter release at the neuromuscular junction. It is primarily used for its muscle-relaxing properties in various medical and cosmetic applications. The toxin acts by blocking the release of acetylcholine, leading to temporary paralysis of the targeted muscles. Because of its potency, botulinum toxin is used in very small doses.

Indications

  • Cervical dystonia
  • Blepharospasm
  • Strabismus
  • Chronic migraine
  • Hyperhidrosis
  • Muscle spasticity
  • Cosmetic use for wrinkle reduction

Dosage

Children: Refer to specific clinical guidelines and product information for dosing, as it varies based on the indication and the specific formulation used.

Adults: Refer to specific clinical guidelines and product information for dosing, as it varies based on the indication and the specific formulation used.

Mechanism of action

Botulinum toxin prevents the release of the neurotransmitter acetylcholine from presynaptic vesicles at the neuromuscular junction. It cleaves proteins essential for the exocytosis of acetylcholine, such as SNAP-25, leading to a reduction in muscle contraction. This action produces a flaccid paralysis of the muscle.

Pharmacodynamics

The effects of botulinum toxin are dose-dependent, and the onset of action varies depending on the indication and dosage. Muscle paralysis typically begins within 24 to 72 hours after injection, and effects can last from three to six months. The therapeutic effects are due to the localized paralysis of overactive muscles, leading to reduced muscle spasticity or improved appearance in cosmetic applications.

Pharmacokinetics

Botulinum toxin is administered via injection, and its pharmacokinetics are characterized by rapid diffusion from the injection site. Systemic absorption is minimal, and the toxin is metabolized in the body, with effects gradually diminishing as the nerve terminals regenerate. The half-life in the systemic circulation is relatively short, but the effects at the neuromuscular junction can last for several months due to the regeneration time of the synaptic terminals.

Contra-indications

  • Hypersensitivity to botulinum toxin or any component of the formulation
  • Infection at the injection site
  • Neuromuscular disorders such as myasthenia gravis or Lambert-Eaton syndrome

Adverse effects

  • Muscle weakness at the injection site
  • Pain and swelling at the injection site
  • Flu-like symptoms
  • Headache
  • Nausea
  • Diplopia (double vision)
  • Ptosis (drooping eyelid)
  • Dry mouth

Precautions

  • Use with caution in patients with respiratory disorders
  • Careful administration in patients with bleeding disorders
  • Pregnant and breastfeeding women should consult healthcare providers before use

Pregnancy

Botulinum toxin is classified as category C. Animal studies have shown adverse effects, but there are no well-controlled studies in pregnant women. It should only be used if clearly needed.

Breast-feeding

It is unknown if botulinum toxin is excreted in human milk. Caution is advised when administering to breastfeeding women.

Storage

Store in a refrigerator at 2-8°C. Do not freeze. Protect from light.

Formulations

  • Botulinum toxin type A
  • Botulinum toxin type B

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: toxin

Toxins are poisonous substances produced by living organisms, such as plants, animals, or microorganisms. They can cause harm or damage to biological systems through various mechanisms, leading to disease or dysfunction. Toxins can be classified into different categories based on their source, structure, and mechanism of action, including neurotoxins, cytotoxins, and enterotoxins. Their effects can range from mild irritation to severe systemic toxicity or even death, depending on the type and amount of toxin involved.

Dosage

Children: Due to the diverse nature of toxins, paediatric dosing guidelines vary widely based on the specific toxin and clinical presentation. Consultation with a toxicologist or pediatric specialist is recommended for appropriate dosing.

Adults: Dosage of toxins is highly variable and depends on the specific toxin involved, the route of exposure, and the clinical scenario. It is crucial to seek expert guidance or refer to specific toxicology resources for accurate dosing information.

Mechanism of action

The mechanism of action of toxins varies widely depending on their type. For instance, neurotoxins disrupt normal neuronal function by inhibiting neurotransmitter release or blocking receptor sites, leading to paralysis or other neurological symptoms. Cytotoxins can induce cell death through apoptosis or necrosis by targeting specific cellular pathways. Enterotoxins typically affect gastrointestinal function, leading to symptoms such as vomiting or diarrhea by altering the activity of intestinal cells.

Pharmacodynamics

Toxins exhibit a dose-dependent relationship with their effects, where lower doses may produce milder symptoms while higher doses can lead to severe toxicity or fatal outcomes. The onset of action and the severity of symptoms depend on individual susceptibility, the route of exposure, and the specific toxin's characteristics. Some toxins can also exhibit cumulative effects if exposure occurs over time, leading to chronic health issues.

Pharmacokinetics

The pharmacokinetics of toxins involves their absorption, distribution, metabolism, and excretion. Many toxins are rapidly absorbed through mucosal surfaces, skin, or ingestion. They are often distributed throughout the body via the bloodstream, where they can bind to various tissues. Metabolism may occur through enzymatic processes in the liver or other organs, and excretion mainly happens via urine or feces. The half-life of toxins can vary significantly based on their chemical structure and the individual's metabolic capacity.

Pregnancy

Toxins can have harmful effects during pregnancy, potentially affecting fetal development. Consultation with a healthcare provider is essential.

Breast-feeding

Toxins may be excreted in breast milk and could pose risks to the infant. Caution is advised.

Storage

Toxins should be stored in a secure location, away from children and pets, and in accordance with specific guidelines applicable to the substance.

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

This drug in other countries

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

Kenya 1 product