Registered Kenya · PPB

NEALGYL 80MG TABLETS

PHLOROGLUCINOL HYDRATE PH.EUR

H2016/CTD3444/768 PHLOROGLUCINOL HYDRATE PH.EUR 80MG GENERIC/BIOSIMILARS INN generic

What it does

Hydrate is used to help maintain proper fluid balance in the body.

Commonly used for: dehydration, fluid imbalance

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2016/CTD3444/768
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
PHLOROGLUCINOL HYDRATE PH.EUR
Strength
-
Pack size
1X10 TABLETS ARE PRESENTED IN BLISTER PACK PER UNIT CARTON, BLISTER CONSISTING OF A SHEET OF PVC / PVDC SEALED ALUMINUM FOIL PRINTED ON LEGAL REGULATIONS.
Therapeutic class
GENERIC/BIOSIMILARS
RxNorm RxCUI
114200
Manufacturer / MAH
Biovail Health
Applicant / LTR
BOTTU S.A
Country of origin
FOREIGN

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:20:19 · updated 2026-07-26 09:19:37

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About hydrate

Hydrate is used to help maintain proper fluid balance in the body.

What it treats

  • dehydration
  • fluid imbalance

How it works

Hydrate helps the body retain water, ensuring that cells and organs function properly.

Who it's for

This is for anyone needing additional fluids, such as those who are dehydrated or have conditions affecting fluid levels.

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

About phloroglucinol

Phloroglucinol is a medication used to relieve pain caused by muscle spasms in the digestive system and other areas.

What it treats

  • abdominal pain (colic)
  • muscle spasms (spasticity)

How it works

It helps to relax the muscles in the stomach and intestines, reducing pain and discomfort.

Who it's for

Adults and children experiencing muscle spasm-related pain.

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

Clinical monograph: hydrate

Hydration therapy involves the administration of fluids to maintain or restore fluid balance in the body. It is critical in treating conditions such as dehydration, which can arise from various causes including excessive fluid loss due to vomiting, diarrhea, or sweating. Hydration can be achieved through oral or intravenous routes, depending on the severity of the condition and the patient's ability to take fluids orally.

Indications

  • Dehydration
  • Electrolyte imbalance
  • Heat-related illnesses
  • Postoperative recovery
  • Diarrhea and vomiting
  • Chronic illnesses leading to fluid loss

Dosage

Children: Pediatric dosing should be guided by clinical guidelines and the severity of dehydration. For children experiencing mild to moderate dehydration, ORS is recommended, with the amount based on weight and age. For severe dehydration, intravenous fluid therapy is indicated, with specific protocols available in pediatric guidelines.

Adults: Dosage varies based on the degree of dehydration and the underlying clinical condition. For mild dehydration, oral rehydration solutions (ORS) are often sufficient, while severe cases may require intravenous fluids, with specific rates and types determined by clinical judgment.

Mechanism of action

Hydration works by replenishing lost fluids and electrolytes, restoring osmotic balance and cellular function. The primary components of hydration solutions, such as water, electrolytes (sodium, potassium, chloride), and sometimes glucose, promote proper cellular hydration and support metabolic processes.

Pharmacodynamics

The pharmacodynamics of hydration primarily involves the restoration of plasma volume and the maintenance of electrolyte homeostasis. Proper hydration enhances kidney function, improves cardiovascular stability, and supports normal physiological functions, such as thermoregulation and nutrient transport. It also aids in the recovery of tissues and organs affected by dehydration.

Pharmacokinetics

The pharmacokinetics of hydration solutions depend on the composition of the fluid administered. Oral hydration solutions are absorbed primarily in the gastrointestinal tract, with the rate of absorption influenced by the concentration of electrolytes and glucose. Intravenous fluids can distribute rapidly into the extracellular space, with effects seen almost immediately. The elimination of excess fluids occurs mainly through renal excretion.

Pregnancy

Hydration is essential during pregnancy, but fluid intake should be monitored to avoid excessive hydration, which can lead to complications.

Breast-feeding

Adequate hydration is important during breastfeeding, as it supports milk production. However, excessive fluid intake should be avoided.

Storage

Store in a cool, dry place away from direct sunlight.

Formulations

  • Oral solutions
  • Intravenous fluids
  • Electrolyte solutions

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: phloroglucinol

BNF-referenced

Phloroglucinol, with the molecular formula C6H6O3, is an organic compound known for its antispasmodic properties. It is primarily used in the treatment of various types of spasms, including gastrointestinal and biliary spasms, making it beneficial in managing conditions such as irritable bowel syndrome and renal colic. Phloroglucinol has been noted for its effectiveness in alleviating abdominal pain associated with these spasms.

Indications

  • Abdominal pain due to spasm
  • Irritable bowel syndrome
  • Renal colic
  • Biliary colic
  • Dysmenorrhea

Dosage

Children: For paediatric doses, refer to the BNF for Children as specific dosing may vary based on age and condition.

Adults: The usual adult dose is 80 mg to 160 mg taken three times daily, depending on the severity of the condition.

Mechanism of action

Phloroglucinol acts as a spasmolytic agent by inhibiting the contraction of smooth muscles, which is mediated through its interaction with the phosphodiesterase enzyme. This leads to increased levels of cyclic AMP and cyclic GMP, resulting in relaxation of smooth muscle and relief from spasms. The compound may also influence neurotransmitter release and modulate pain perception in the gastrointestinal tract.

Pharmacodynamics

Phloroglucinol exhibits dose-dependent effects on smooth muscle relaxation. Its spasmolytic activity is attributed to its ability to decrease muscle tone and motility, thereby providing symptomatic relief from painful spasms. The onset of action is typically rapid, and the duration of effect can vary based on the route of administration and the specific condition being treated.

Pharmacokinetics

After oral administration, phloroglucinol is rapidly absorbed and reaches peak plasma concentrations within 1 to 2 hours. It is metabolized primarily in the liver, with a significant first-pass effect. The elimination half-life is relatively short, necessitating multiple doses for sustained effect. Renal excretion is the primary route of elimination for its metabolites.

Pregnancy

There is limited data on the use of phloroglucinol during pregnancy. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Phloroglucinol is excreted in breast milk. Caution should be exercised when administering to nursing mothers.

Storage

Store at room temperature, away from light and moisture.

Formulations

  • Tablets
  • Oral solution

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.