VERTIGOHEEL® is a homeopathic combination formulation for the treatment of vertigo consisting of 2 botanical substances, 1 zoological substance, and 1 mineral substance (1, 2). VERTIGOHEEL® is officially classified as a homeopathic combination remedy.
Tablets: Each 300 mg tablet contains as active ingredients: Cocculus indicus 4X 210 mg; Conium maculatum 3X 30 mg; Ambra grisea 6X 30 mg; Petroleum 8X 30 mg; in a lactose base. Each 300 mg tablet contains as an inactive ingredient: Magnesium stearate.
Oral Drops: Each 100 ml of solution contains as active ingredients: Cocculus indicus 4X 70 ml; Conium maculatum 3X 10 ml; Ambra grisea 6X 10 ml; Petroleum 8X 10 ml. Contains ethyl alcohol 35% by volume.
Oral Liquid in Vials: Each 100 ml of solution contains as active ingredients: Cocculus indicus 3X 0.7 ml; Conium maculatum 2X 0.1 ml; Ambra grisea 5X 0.1 ml; Petroleum 7X 0.1 ml. Each 100 ml of solution contains as an inactive ingredient: Isotonic sodium chloride solution.
The exact mechanism of action of VERTIGOHEEL® is not fully understood. Pharmacologic studies suggest that the effectiveness of VERTIGOHEEL® for the treatment of vertigo and nausea, and for improving vestibulo-ocular and proprioceptive symptoms, is due in part to central nervous system stimulation. Studies have confirmed that VERTIGOHEEL® activates the vestibular regulatory systems located in the brainstem area. Computer-processed brain mapping recordings indicate an increase in activity in the neuropathways, which connect the vestibulo-pathways with the corpora quadrigemina (3, 4).
Clinical Studies: In a randomized, double blind, controlled clinical study (119 patients) Vertigoheel® reduced the frequency, duration, and intensity of the vertigo attacks during a 6-week treatment period; effectiveness and tolerability was good compared to betahistine (5).
VERTIGOHEEL® is indicated for the treatment of vertigo (3,4,5) and other related imbalance disorders, and related symptoms such as nausea. VERTIGOHEEL® is also indicated for the prevention and treatment of motion sickness (6).
VERTIGOHEEL® is contraindicated in patients with a known hypersensitivity to VERTIGOHEEL® or any of its ingredients.
VERTIGOHEEL® should not be administered for more than 10 days for adults or 5 days for children without follow-up assessment by a physician. If during the course of treatment symptoms persist or worsen, or if new symptoms occur, the patient should consult a physician because these could be signs of a serious condition requiring more aggressive therapy.
Adverse effects with VERTIGOHEEL® are extremely rare. VERTIGOHEEL® exhibits no known adverse renal, hepatic, cardiovascular, gastrointestinal, or central nervous system effects.
No harmful or potentially hazardous side effects such as central nervous system depression are known. VERTIGOHEEL® is generally well-tolerated even during long term administration.
VERTIGOHEEL® is not known to interact with other medications.
VERTIGOHEEL® is not known to interact with any laboratory tests.
No studies have been performed to evaluate the carcinogenicity of VERTIGOHEEL®. In world-wide post-marketing surveillance no evidence of carcinogenicity has been found (5).
Pregnancy Category C. In general, medications such as VERTIGOHEEL® which are classified as homeopathic are not known to cause direct or indirect harm to the fetus. However, animal reproduction studies have not been performed and there are no well-controlled studies in pregnant women. In cases of pregnancy or suspected pregnancy, a physician should be consulted before administering VERTIGOHEEL®.
It is not known whether any of the ingredients in VERTIGOHEEL® are excreted in human milk. However, because many drugs are excreted in human milk, VERTIGOHEEL® should be administered with caution to nursing mothers.
VERTIGOHEEL® Tablets and VERTIGOHEEL® Oral Liquid in Vials can be safely administered to children as young as 2 years (see DOSAGE AND ADMINISTRATION ). However, due to its alcohol content (ethyl alcohol 35% by volume), VERTIGOHEEL® Oral Drops should be administered with caution to children below the age of 12 years.
VERTIGOHEEL® exhibits no known adverse reactions.
Due to the low concentrations of active ingredients in homeopathic preparations such as VERTIGOHEEL®, adverse reactions following overdosage are extremely unlikely. However, care must be taken not to exceed the recommended dosage.
The dosage schedules listed below can be used as a general guide for the administration of VERTIGOHEEL®. The dosage for each patient should be individualized according to the patient' response to therapy. For the treatment or prevention of vertigo or motion sickness, the onset of action of VERTIGOHEEL® may not be immediate. Patients responding to VERTIGOHEEL® therapy will normally show benefit within one week (5,6). The frequency of administration of the 3 dosage forms may be increased to every 15 minutes over a 2-hour period for acute exacerbations of the symptoms of vertigo, in both children and adults, unless otherwise directed by a physician. VERTIGOHEEL® Tablets, Oral Drops, and Oral Liquid in Vials should be administered at least 30 minutes after meals and when the oral cavity is free of food material. For best results, treatment with VERTIGOHEEL® should be initiated at the first sign of symptoms and continued for a physician-specified period. If symptoms persist or worsen, the patient should contact a physician (see ).
VERTIGOHEEL® Tablets:
Adults and Children above 6 years: 2 to 3 tablets sublingually or dissolved completely in the mouth 3 times daily.
Children 2 to 6 years: 1 to 2 tablets sublingually or dissolved completely in the mouth 3 times daily.
For best results, VERTIGOHEEL® Tablets should be dissolved under the tongue or in the mouth since the absorption is via the buccal lining. For small children tablets may be divided or crushed for easier administration.
Adults and Children above 11 years: 15 to 20 drops taken sublingually 3 times daily.
Children 2 to 11 years: Half the adult dosage. Due to its alcohol content (ethyl alcohol 35% by volume), VERTIGOHEEL® Oral Drops should be administered with caution to children below the age of 12 years.
VERTIGOHEEL® Oral Drops may be added to clear, non-sparkling water prior to administration.
VERTIGOHEEL® Oral Liquid in Vials:
Adults and Children above 6 years: The contents of 1 vial taken orally 1 to 3 times daily.
Children 2 to 6 years: Half the contents of 1 vial taken orally 1 to 3 times daily.
VERTIGOHEEL® Oral Liquid in Vials may be added to clear, non-sparkling water prior to administration. Note: The unused portion of the open vials should be discarded. NOT FOR INJECTION.
VERTIGOHEEL® Tablets (white, unscored with "Heel" impressed on one side) in bottles of 100: NDC 50114-6155-2. Avoid freezing and excessive heat. Store at room temperature. Keep container tightly closed. Protect from light and moisture.
VERTIGOHEEL® Oral Drops in 50 ml (1.6 fluid oz) bottles: NDC 50114-1170-4. Avoid freezing and excessive heat. Store at controlled room temperature. Keep container tightly closed. Protect from light.
VERTIGOHEEL® Oral Liquid in Vials, 1.1 ml packs of 10: NDC 50114-1122-4. Avoid freezing and excessive heat. Store at controlled room temperature. Protect from light.