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Spascupreel

Package insert / prescribing information
Generic name: homeopathic product
Dosage form: injection

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Spascupreel Description

Each 1.1 ml solution for injection ampule contains:
Active Ingredients:
Ingredient name Potency Quantity Final dilution
Aconitum napellus 6X 2.20 µl 8.69X
Agaricus muscarius 4X 0.55 µl 7.30X
Ammonium bromatum 4X 1.10 µl 7.00X
Atropinum sulphuricum 6X 1.10 µl 8.99X
Chamomilla 3X 0.55 µl 6.30X
Colocynthis 4X 1.10 µl 7.00X
Cuprum sulphuricum 6X 0.55 µl 9.30X
Gelsemium sempervirens 6x 1.10 µl 8.99X
Magnesia phosphorica 6X 1.10 µl 8.99X
Passiflora incarnata 2X 0.55 µl 5.30X
Veratrum album 6X 1.10 µl 8.99X

Inactive Ingredients:

Water for injection 1,089.0 μl

Sodium Chloride 10.4 μl

INDICATION AND USAGE

Spascupreel® Injection Solution is a homeopathic drug product indicated for the relief of spasms of the smooth musculature of the gastrointestinal and the urogenital tract as well as general muscle spasms.

Spascupreel Dosage and Administration

General Considerations

  • The dosage schedules listed below can be used as a general guide for the administration of Spascupreel® Injection Solution.
  • Spascupreel® Injection Solution may be administered s.c., i.d., i.m., or i.v.
  • If co-administration with a local anesthetic is desired, Spascupreel®Injection Solution may be mixed with lidocaine or similar agents at the discretion of the physician.

  • The interval between injections is left to the discretion of the HCP, but should not exceed 1 ampule in 24 hours.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard any unused ampule contents.
  • Draw up required dose into syringe.
  • Discard any unused ampule contents. Do not reuse ampule.
  • Only licensed practitioners with sufficient expertise in injecting drugs, including the respective route of administration, should administer the product.

Standard Dosage:

Adults and children 12 years and older: 1 ml 1 to 3 times per 7 days.

Children 6 to 11 years: 0.7 ml 1 to 3 times per 7 days.

Children 2 to 5 years: 0.5 ml 1 to 3 times per 7 days.

Acute Dosage:

Adults and children 12 years and older: 1 ml daily, and then continue with standard dosage.

Children 6 to 11 years: 0.7 ml daily, and then continue with standard dosage.

Children 2 to 5 years: 0.5 ml daily, and then continue with standard dosage.

Contraindications

Spascupreel® Injection Solution is contraindicated in patients with known hypersensitivity to Spascupreel® or any of its ingredients.

Warnings and Precautions

Keep out of reach of children.

Adverse Reactions

Post-marketing Experience

  • No adverse events have been reported with a causal relationship to Spascupreel® injection solution.
  • To report SUSPECTED ADVERSE REACTIONS, contact MediNatura. at 1.844.633.4628 or info@medinatura.com or FDA at1-800-FDA-1088

    or www.fda.gov/medwatch.

Spascupreel - Clinical Pharmacology

Mechanism of Action

The exact mechanism of Spascupreel® Injection Solution is not fully understood.

Pharmacodynamics

Not applicable for homeopathic medicinal products.

DOSAGE

1 ampule containing 1.1 ml solution for injection.

Spascupreel
aconitum napellus, ammonium bromide, citrullus colocynthis fruit pulp, atropine sulfate, gelsemium sempervirens root, magnesium phosphate, dibasic trihydrate, veratrum album root, passiflora incarnata flowering top, matricaria recutita, amanita muscaria fruiting body and cupric sulfate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50114-7040
Route of Administration INTRADERMAL, INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 6 [hp_X] in 1.1 mL
AMMONIUM BROMIDE (BROMIDE ION) AMMONIUM BROMIDE 4 [hp_X] in 1.1 mL
CITRULLUS COLOCYNTHIS FRUIT PULP (CITRULLUS COLOCYNTHIS FRUIT PULP) CITRULLUS COLOCYNTHIS FRUIT PULP 4 [hp_X] in 1.1 mL
ATROPINE SULFATE (ATROPINE) ATROPINE SULFATE 6 [hp_X] in 1.1 mL
GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X] in 1.1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (MAGNESIUM CATION) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_X] in 1.1 mL
VERATRUM ALBUM ROOT (VERATRUM ALBUM ROOT) VERATRUM ALBUM ROOT 6 [hp_X] in 1.1 mL
PASSIFLORA INCARNATA FLOWERING TOP (PASSIFLORA INCARNATA FLOWERING TOP) PASSIFLORA INCARNATA FLOWERING TOP 2 [hp_X] in 1.1 mL
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA 3 [hp_X] in 1.1 mL
AMANITA MUSCARIA FRUITING BODY (AMANITA MUSCARIA FRUITING BODY) AMANITA MUSCARIA FRUITING BODY 4 [hp_X] in 1.1 mL
CUPRIC SULFATE (CUPRIC CATION) CUPRIC CATION 6 [hp_X] in 1.1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description
1 NDC:50114-7040-1 10 AMPULE in 1 CARTON
1 1.1 mL in 1 AMPULE
2 NDC:50114-7040-2 1 AMPULE in 1 CARTON
2 1.1 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 08/30/2014 11/30/2023
Labeler - MediNatura Inc (102783016)
Establishment
Name Address ID/FEI Operations
Hameln Pharma GmbH 315869123 manufacture(50114-7040)
Establishment
Name Address ID/FEI Operations
Biologische Heilmittel Heel 315635359 manufacture(50114-7040)
MediNatura Inc