Spazmovaks^® (Solution) Instructions for Use

Marketing Authorization Holder

Sharper S.p.A. (Italy)

Manufactured By

Doppel Farmaceutici, S.r.l. (Italy)

ATC Code

A03AX12 (Phloroglucinol)

Active Substance

Phloroglucinol (BAN)

Dosage Form

Spazmovaks®

Solution for intravenous and intramuscular injection 40 mg/4 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular injection transparent, colorless or practically colorless.

Excipients : sodium chloride – 28 mg, sodium metabisulfite – 3 mg, sodium sulfite – 1 mg, water for injections up to 4 ml.

4 ml – ampoules (10) – PVC trays (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with antispasmodic action for the treatment of diseases of the biliary and urinary tracts

Pharmacotherapeutic Group

Other medicinal products for the treatment of functional gastrointestinal disorders

Pharmacological Action

Antispasmodic agent used to control pain caused by acute and chronic disorders of the urinary and biliary systems.

It exerts an antispasmodic effect by inhibiting the activity of catechol-O-methyltransferase in tissues, thus interfering with catecholamine catabolism, which leads to a subsequent increase in sympathetic tone.

It has been established that Phloroglucinol and its methylated derivative, trimethoxybenzene, do not lead to a change in the physiological tone of smooth muscles, as they act selectively on smooth muscle tissues in a state of spasm.

Intensive antispasmodic activity was also noted for the sphincter of Oddi, which was confirmed by studies on dogs with the gallbladder removed, which were treated with BaCl₂.

Pharmacokinetics

In animals, the T_1/2 of tritium-labeled phloroglucinol from plasma was 15 min.

The concentration of the active substance rapidly decreases up to the 4th hour.

The concentration of the drug is maximal in the kidneys, liver, and intestines.

24 hours after administration, radioactivity is not detected.

When phloroglucinol (40 mg/4 ml) is administered to healthy volunteers, the T_1/2 is 1.28±0.18 h.

Indications

Pain and spasms in the urinary tract, acute renal colic as an auxiliary therapy.

Acute biliary colic in cholelithiasis or spastic conditions in diseases of the biliary tract or spasm caused by biliary dyskinesia.

Symptomatic treatment of pain associated with functional gastrointestinal disorders.

ICD codes

Dosage Regimen

Administer Spazmovaks^®intravenously or intramuscularly.

The standard adult dose is 40 mg (one 4 ml ampule) per administration.

Determine the frequency of administration based on the patient’s clinical response and pain intensity.

For acute renal colic or acute biliary colic, administer as needed to control severe spasmodic pain.

In functional gastrointestinal disorders, adjust the dosing interval to maintain symptomatic relief.

Do not exceed the maximum recommended duration of therapy of 5 to 7 days.

Transition to oral antispasmodic therapy as soon as clinically appropriate.

This product is contraindicated in children and adolescents under 18 years of age.

Adverse Reactions

From the immune system unspecified frequency – anaphylactic shock; very rarely – angioedema.

From the cardiovascular system unspecified frequency – decreased blood pressure.

From the skin and subcutaneous tissues rarely – urticaria; unspecified frequency – rash, acute generalized exanthematous pustulosis.

Contraindications

Hypersensitivity to phloroglucinol; children and adolescents under 18 years of age; breastfeeding period.

Use in Pregnancy and Lactation

In animal studies, the use of phloroglucinol did not reveal teratogenic effects.

Since teratogenic effects were not detected in animals, it is considered that malformations in humans are unlikely.

Currently, in special studies conducted to study teratogenicity, it has been shown that substances responsible for malformations in humans are teratogenic in animals.

To date, the relatively wide clinical use of phloroglucinol has not revealed a risk of malformations.

Phloroglucinol is used only in case of extreme necessity under the supervision of the attending physician if the potential benefit to the mother outweighs the risk to the fetus.

Breastfeeding period

Contraindicated for use during breastfeeding.

Use in Hepatic Impairment

There are no data on the use of phloroglucinol in patients with hepatic insufficiency.

Use in Renal Impairment

There are no data on the use of phloroglucinol in patients with renal insufficiency.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Use with caution during breastfeeding.

Drug Interactions

It is not recommended to use simultaneously with potent painkillers, such as morphine or its derivatives, due to their spasmogenic action.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.