Botulinum Toxin Type B

Table of contents

  • Brand Names
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Unlabeled Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Toxicological Effects
  • Genes that may be involved
  • Drug Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics

Brand Names

Europe

Austria: NeuroBloc; Belgium: NeuroBloc; Bulgaria: NeuroBloc; Cyprus: NeuroBloc; Czech Republic: NeuroBloc; Denmark: NeuroBloc; Estonia: NeuroBloc; Finland: NeuroBloc; France: NeuroBloc; Germany: NeuroBloc; Greece: NeuroBloc; Hungary: NeuroBloc; Ireland: NeuroBloc; Italy: NeuroBloc; Latvia: NeuroBloc; Lithuania: NeuroBloc; Luxembourg: NeuroBloc; Malta: NeuroBloc; Netherlands: NeuroBloc; Poland: NeuroBloc; Portugal: NeuroBloc; Romania: NeuroBloc; Slovakia: NeuroBloc; Slovenia: NeuroBloc; Spain: NeuroBloc; Sweden: NeuroBloc; UK: NeuroBloc.

North America

USA: Myobloc.

Drug combinations

Chemistry

Pharmacologic Category

Skeletal Muscle Relaxants, Miscellaneous. Other Miscellaneous Therapeutic Agents. (ATC-Code: M03AX01).

Mechanism of action

Neurotoxin produced by Clostridium botulinum. Blocks neuromuscular conduction by binding to receptor sites on motor nerve terminals, entering the nerve terminals and inhibiting the release of acetylcholine. By blocking neurotransmitter release, it induces chemical denervation and flaccid paralysis by disruption of neurotransmission. Inhibits sweat production by blocking release of acetylcholine, which mediates sympathetic neurotransmission in eccrine glands.

Therapeutic use

Cervical dystonia (spasmodic torticollis).

Pregnancy and lactiation implications

Reproduction studies not conducted. Based on limited case reports using botulinum toxin A, adverse fetal effects not observed with inadvertent administration during pregnancy. Use with caution during lactation.

Unlabeled use

Cervical dystonia in patients who have developed resistance to botulinum toxin type A. Cosmesis for temporary improvement in the appearance of facial wrinkles associated with hyperactivity of the orbiculus oculi muscle (lateral canthal wrinkles, also known as «crow’s feet»).

Contraindications

Hypersensitivity to albumin, botulinum toxin, or any component of the formulation. Infection at the injection site(s). Relative contraindications include diseases of neuromuscular transmission, and coagulopathy (including therapeutic anticoagulation).

Warnings and precautions

Hypersensitivity and anaphylactic reactions may occur. Neutralizing antibody formation and loss of efficacy (with higher doses or more frequent administration). Dysphagia is common when used for cervical dystonia, and may be associated with increased risk of upper respiratory infection. Caution in neuromuscular diseases (myasthenia gravis), neuropathic disorders (amyotrophic lateral sclerosis), or patients taking aminoglycosides or other drugs that interfere with neuromuscular transmission. Formulation contains human albumin derived from blood and so theoretical but remote risk of transmission of Creutzfeldt-Jakob disease via albumin component exists (no cases identified to date). Concurrent use of botulinum toxin type A or within <4 months of type B is not recommended. Use with caution if there is inflammation, excessive weakness, or atrophy at the proposed injection site(s). Serious adverse events (including fatalities) in association with the use of botulinum types A and type B described. Incidence of autonomic effects (e.g. anticholinergic effects such as dry mouth, ptosis, accommodation difficulty) may be higher with botulinum toxin type B than with type A. Ecchymosis at the injection site reported (administer with caution to patients with thrombocytopenia or bleeding disorder or those receiving anticoagulant therapy).

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