Frezza Mint

Frezza Mint Uses, Dosage, Side Effects, Food Interaction and all others data.

A clear, colorless liquid rapidly absorbed from the gastrointestinal tract and distributed throughout the body. It has bactericidal activity and is used often as a topical disinfectant. It is widely used as a solvent and preservative in pharmaceutical preparations as well as serving as the primary ingredient in alcoholic beverages.

Alcohol produces injury to cells by dehydration and precipitation of the cytoplasm or protoplasm. This accounts for its bacteriocidal and antifungal action. When alcohol is injected in close proximity to nerve tissues, it produces neuritis and nerve degeneration (neurolysis). Ninety to 98% of ethanol that enters the body is completely oxidized. Ethanol is also used as a cosolvent to dissolve many insoluble drugs and to serve as a mild sedative in some medicinal formulations. Ethanol also binds to GABA, glycine, NMDA receptors and modulates their effects. Ethanol is also metabolised by the hepatic enzyme alcohol dehydrogenase.

Glycerin is a hyperosmotic laxative, given rectally, which usually produces a bowel movement within 15 minutes to 1 hour. Hyperosmotic laxatives encourage bowel movements by drawing water into the bowel from surrounding tissues. This produces a softer stool mass and increased bowel action. These products are used for fast, predictable relief of occasional constipation.

Glycerin is commonly classified as an osmotic laxative but may act additionally or alternatively through its local irritant effects; it may also have lubricating and fecal softening actions. Glycerin suppositories usually work within 15 to 30 minutes.

Peppermint Oil helps to relieve both the painful abdominal spasm and uncomfortable bloating of IBS. It has a relaxant, antispasmodic effect especially on the muscles of the large bowel or colon and in bowel spasm, particularly large-bowel spasm. It is carminative, antibacterial, mucolytic. Peppermint Oil helps to treat unpleasant sensations of fullness and bloating and facilitates the passing of bowel gases, so relieving accompanying cramp like pain.

Peppermint oil induces a dose-related antispasmodic effects on the gastrointestinal smooth muscles . A meta-analysis study and additional clinical studies of patients with IBS demonstrated that the treatment with peppermint oil improves abdominal symptoms compared to the placebo group, resulting in reduced severity of abdominal pain, decreased abdominal distension, reduced stool frequency, and reduced flatulence . The use of enteric-coated peppermint oil was shown to be effective in reducing gastrointestinal symptoms of non-ulcer dyspepsia . In rats, peppermint oil promoted a time-dependent choleretic effect in increasing bile production and biliary output . In randomized controlled trials, topical application of peppermint oil was associated with a significant analgesic effect and a reduction in headache intensity compared to placebo . In a study of C57BL/6 mice, topical application of peppermint oil for 4 weeks was associated with a prominent hair growth effects; a significant increase in dermal thickness, follicle number, and follicle depth .

Sodium fluoride is a cariostatic agent that is used to prevent dental caries. It can also be used as a source of fluoride in total parenteral nutrition.

Sodium fluoride protects the teeth from acid demineralization while preventing tooth decay by bacteria while strengthening tooth enamel. It is important to note that excess fluoride exposure during tooth mineralization, especially in children 1-3 years old, may cause fluorosis. It is a condition manifested by white lines, pitting, or discoloration of teeth resulting from changes in tooth enamel. The risk of fluorosis can be decreased by the use of a rice-size amount of fluoridated toothpaste in children younger than 3 years old. It is recommended that no more than a pea-sized quantity of fluoridated toothpaste should be used for children from 3 to 6 years old. The American Dentistry Association (ADA) recommends that children should be closely supervised during toothpaste use to prevent excess fluoride ingestion.

Spearmint allergenic extract is used in allergenic testing.

Frezza Mint
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Frezza Mint
Generic	Sodium Fluoride + Menthol + Peppermint Oil + Citric Cyclamate + Glycerin + Polyoxyl + Spearmint + Ethanol + dan Purified water
Weight	40hydrogenatedcastoroil
Type	Fluid Kumur
Therapeutic Class
Manufacturer	Konimex
Available Country	Indonesia
Last Updated:	September 19, 2023 at 7:00 am

Uses

For therapeutic neurolysis of nerves or ganglia for the relief of intractable chronic pain in such conditions as inoperable cancer and trigeminal neuralgia (tic douloureux), in patients for whom neurosurgical procedures are contraindicated.

For the relief of occasional constipation

Each enteric coated liquid filled hard gelatin capsule contains 187 mg (0.2 ml) of peppermint oil.

Peppermint Oil is used in Irritable bowel syndrome (IBS), Functional dyspepsia, Abdominal pain and spasm, Abdominal distension/bloating

Peppermint leaf preparations consist of the fresh or dried leaf of Mentha x piperita L. The whole dried leaf must contain not less than 1.2% (ml/gm) and the cut leaf must contain not less than 0.9% volatile oil. Peppermint oil consists of the essential oil, obtained by steam-distilling freshly harvested, flowering springs and is neither partially nor wholly dementholized.

Sodium fluoride is an antiseptic & anticavity mouthwash which-

Restores enamel to strengthen teeth
Protects teeth from cavity
Helps to prevent tooth decay
Controls tartar that can discolor teeth
whitens teeth safety

Spearmint is an extract from Spearmint used in allergy testing.

Frezza Mint is also used to associated treatment for these conditions: Bacterial Infections, Obstructive Hypertrophic Cardiomyopathy, Skin Infections, Bacterial, Skin Irritation, Ethylene glycol overdose, Fat occlusion in central venous catheter, Methanol overdose, Hand Hygiene, Skin disinfectionCold Sore, Constipation, Dry Mouth, Dry Skin, Dry throat, Edema of the cerebrum, Hypertension Intracranial, Occasional Constipation, Ocular Discomfort, Ocular Hypertension, Ocular Irritation, Skin Infections, Sore Throat, Mouth soreness, Ocular burning, Bowel preparation therapy, Topical Antisepsis, Skin protectionColic, Cough, Flatulence, Hypertonicity of the small intestine, Irritable Bowel Syndrome (IBS), Mild pain, Nasal Congestion, Soreness, Muscle, Gas painCaries; Enamel, Cavity, Dental Cavity, Dental Decay, Dental Health, Partial Denture Wearers Wear of the Natural Enamel, Tooth Sensitivity, Trace Element Deficiency, Wear of the Natural Enamel caused by teeth grinding, Parenteral Nutrition

How Frezza Mint works

Ethanol affects the brain’s neurons in several ways. It alters their membranes as well as their ion channels, enzymes, and receptors. Alcohol also binds directly to the receptors for acetylcholine, serotonin, GABA, and the NMDA receptors for glutamate. The sedative effects of ethanol are mediated through binding to GABA receptors and glycine receptors (alpha 1 and alpha 2 subunits). It also inhibits NMDA receptor functioning. In its role as an anti-infective, ethanol acts as an osmolyte or dehydrating agent that disrupts the osmotic balance across cell membranes.

When administered rectally, glycerin exerts a hygroscopic and/or local irritant action, drawing water from the tissues into the feces and reflexively stimulating evacuation. Glycerin decreases intraocular pressure by creating an osmotic gradient between the blood and intraocular fluid, causing fluid to move out of the aqueous and vitreous humors into the bloodstream.

Dose-dependent antispasmodic effect of peppermint oil is largely mediated by its menthol constituent . It is proposed that peppermint oil relaxes gastrointestinal smooth muscle and attenuates contractile responses by reducing the influx of extracellular calcium ions. In rabbit jejunum smooth muscle cells investigated via whole cell clamp configuration technique, peppermint oil was shown to inhibit the potential-dependent calcium currents in a concentration-dependent manner . Both a reduction in peak current amplitude and an increase in the rate of current decay were observed, indicating that the pharmacological activity peppermint oil resembles that of dihydropyridine calcium antagonists . In a rat small intestine study, peppermint oil in the intestinal lumen inhibited enterocyte glucose uptake via a direct action on the brush border membrane and inhibited intestinal secretion . There is also evidence that menthol is an antagonist of L-type Ca2+ channels via interacting with dihydropyridine binding sites and blocks the currents of low-voltage-activated calcium channels . Peppermint oil may facilitate hair growth by promoting the conservation of vascularization of hair dermal papilla, which may contribute to the induction of early anagen stage of active growth phase of hair follicles .

The prevention of dental caries by topical fluoride is achieved by various mechanisms. Sodium fluoride kills bacteria that cause caries, such a Streptococcus mutans and lactobacilli by interfering with their metabolic activities that result in the formation of lactic acid. Fluoride ions cause the inhibition of glycolytic and other enzymes involved in bacterial metabolism. It changes the permeability of cell membranes, lowering the pH in the cytoplasm of the cell, leading to a decrease in acidity, which is normally implicated in tooth decay.

When administered at low topical doses, fluoride in both saliva and plaque and saliva prevent the demineralization of healthy tooth enamel while remineralizing teeth that have previously been demineralized. Sodium fluoride is absorbed by the surface of hydroxyapatite crystals on the teeth, which are necessary for mineralization. This renders the teeth more resistant to demineralization by changing the apatite crystal solubility. Sodium fluoride inhibits the demineralization of teeth in a pH-related manner. When used in high doses, in formulations such as the fluoride varnishes or gels, sodium fluoride forms a layer on the surface of tooth enamel. When the pH of the mouth is reduced due to acid production by bacteria such as S.mutans, fluoride is released, interfering with bacterial metabolism, and then acts to remineralize the teeth.

Dosage

Frezza Mint dosage

Children under 2 years: Consult a physician.

Children (2 to 6 years): only 1 Glycerin 1.15 suppository per 24 hours or as directed by a physician.

Adults and Children (From 6 years): only 1 Glycerin 2.30 suppository per 24 hours or as directed by a physician

Insert suppository well up into rectum. Suppository need to melt completely to produce laxative action.

Adults: 1 capsule 3 times daily with a glass of water. The dose may be increased to a maximum of 2 capsules 3 times daily or as directed by a physician.

Children (8 years and above): 1 capsule 3 times daily with a glass of water or a directed by a physician.

Rinse (gargle) with fall strength Sodium fluoride for 30 seconds with 20 ml (with the help of supplied cup) two times daily (morning and evening). Do not swallow. Don’t eat or drink within 30 minutes after rinsing with Sodium fluoride restoring.

Side Effects

Glycerin when used rectally may cause rectal discomfort or a burning sensation

Hypersensitivity reactions, rash, nausea, vomiting. Products containing stannous fluoride may cause teeth staining.

Toxicity

Oral, rat LD₅₀: 5628 mg/kg. Symptoms and effects of overdose include nausea, vomiting, CNS depression, acute respiratory failure or death and with chronic use, severe health problems, such as liver and brain damage.

Glycerol has very low toxicity when ingested ; Rat LD50 (oral)-12600mg/kg Mice LD50 (oral )-4090mg/kg Human TDLo (oral) - 1428mg/kg

Oral LD50 value in rat is 2426 mg/kg . In fasted mice, the LD50 following oral administration was 2410 mg/kg . Higher doses of peppermint oil has the potential to induce menstruation, bronchospasm, tongue spasms, and, possibly, respiratory arrest in addition to potential hepatotoxicity and nephrotoxicity .

Overdose may cause severe gastrointestinal symptoms, diarrhoea, rectal ulceration, epileptic convulsions, loss of consciousness, apnoea, nausea, disturbances in cardiac rhythms, ataxia and other CNS problems, probably due to the presence of menthol . In the event of overdose, the stomach should be emptied by gastric lavage. Observation should be carried out with symptomatic treatment if necessary . A near fatal case of high dose peppermint oil ingestion was reported, the overdose was characterized by comatose and reduced heart rate .

The oral LD50 of sodium fluoride is 44 mg/kg in mice and 31 mg/kg in rats. The oral LD50 of sodium fluoride in rabbits is 200 mg/kg.

Overdose information

The ingestion of toothpaste is the major cause of sodium fluoride overdose. This is followed by sodium fluoride supplements and mouth rinses. Most causes of sodium fluoride toxicity have been observed in children under the age of 6 years old. The manifestations of a sodium fluoride overdose may include gastrointestinal disturbance, abdominal pain, alterations in taste, seizures, salivation, bradycardia, tachycardia, headache, tremor, and shallow breathing. Gastrointestinal bleeding may also occur in addition to a sensation of burning in the mouth. Hypotension, bronchospasm, fixed mydriasis, and elevated potassium can also occur which, in turn, may lead to arrhythmias and cardiac arrest.

Management

If a dose greater than 5 mg fluoride per kilogram of body weight (2.3 mg fluoride per pound of body weight) has been taken, it is advisable to induce vomiting. Administer calcium in an oral, soluble form (for example, 5% calcium gluconate, a solution of calcium lactate, or milk). The patient should seek immediate medical attention. If a sodium fluoride ingestion of 15 mg fluoride/kg of body weight or more occurs (i.e. higher than 6.9 mg fluoride per pound), immediately induce vomiting, provide supportive care, and admit the patient to the hospital for observation.

Precaution

Should not be taken with food or immediately after meals. Should be taken 30 to 60 minutes before meals. Must be swallowed whole, with a little liquid. Capsules must not be chewed or crushed.

Prolonged treatment with large amounts of fluoride may result in dental fluorosis and osseous changes; do not exceed recommended dosage. Renal impairment. Pregnancy.

Interaction

Exacerbation of adverse effects if taken with alcohol; enteric-coated preparations containing peppermint oil should not be taken immediately with antacids.

Absorption of fluoride may be reduced by aluminium, calcium and magnesium salts.

Volume of Distribution

Glycerin is distributed throughout the blood. Although glycerin generally does not appear in ocular fluids, it may enter the orbital sac when the eye is inflamed, with a consequent decrease in osmotic effect.

No pharmacokinetic data available.

Fluoride distributes to the saliva, bones, and teeth, and is also found in lesser quantities in the breastmilk and sweat. After the ingestion of sodium fluoridated drinking water, the fluoride ions are found to distribute to the plasma and blood cells. Plasma levels of fluoride concentrations are twice as the concentrations found in blood cells. Adults have been found to retain 36% of ingested fluoride and children have been found to retain about 50% of a dose. Most of the retained fluoride is localized to bone and teeth and 1% accumulates in soft tissues. Fluoride crosses the placenta and the blood-brain barrier. The central nervous system concentrations of sodium fluoride are estimated to reach 20% the plasma concentrations. Studies conducted in communities with high levels of fluoride in water did not show any increase in birth defects. The placenta is able to regulate the accumulation of excess fluoride, possibly protecting the fetus from high levels of fluoride. Despite this, excessively high exposure to fluoride in utero may lead to skeletal fluorosis.

Elimination Route

Rapidly absorbed.

Well absorbed orally, poorly absorbed rectally. Studies in humans and animals indicate glycerol is rapidly absorbed in the intestine and the stomach

After oral administration, peppermint is rapidly absorbed . Menthol is highly fat-soluble therefore rapidly absorbed from the proximal gut .

Sodium fluoride is 90% absorbed from the gastrointestinal tract, with 77% of absorption in the proximal intestine and about 25% in the stomach. The rate of absorption may vary according to gastric pH. Cmax is reached 20-60 minutes after ingestion. Cmax was estimated to be 848 ± 116 ng/mL after a 20mg sodium fluoride solution was ingested, with a Tmax of 0.46 ± 0.17 hours. The bioavailability of sodium fluoride tablets administered in the fasted state during one pharmacokinetic study approached 100%. Another resource reports a sodium fluoride AUC of 1.14 ± 0.12 μg × h/mL after the ingestion of fluoridated water.

Half Life

30 - 45 minutes

No pharmacokinetic data available.

The terminal plasma elimination half-life following the ingestion of fluoridated drinking water generally ranges from 3 to 10 hours. The half-life of sodium fluoride in the bones is 20 years.

Clearance

No pharmacokinetic data available.

Sodium fluoride is rapidly cleared by the kidneys and depends on various factors, including glomerular filtration rate, urine flow, and urine pH. According to one clinical study evaluating the pharmacokinetics of oral sodium fluoride tablets in healthy young adults, the renal clearance was determined to be 77.4 ± 11.2mL/min for acidic urine and 78.4 ± 6.9mL/min for alkaline urine. Another reference estimates the renal clearance of fluoride ions from sodium fluoridated water at 35–45 mL/min.

Elimination Route

Approx 7-14% of dose is excreted unchanged in the urine within 2.5 hr.

Peppermint oil is eliminated mainly via the bile following oral administration, with glucuronide and sulphate metabolites predominant . The metabolites, mainly menthol glucuronide and mono- or di-hydroxylated menthol derivatives, may also undergo approximately equal renal and fecal excretion . Renal recovery of total menthol within 24 hours was dose-dependent whereas the recovery in bile was substantially higher over 8 hours .

Sodium fluoride is rapidly excreted, mainly in the urine. About 90% of fluoride is filtered by the glomerulus and reabsorbed by the renal tubules. About 10% is excreted in the feces.

Pregnancy & Breastfeeding use

Pregnancy category C. There are no controlled data in human pregnancy

No known restrictions.

Contraindication

Sensitivity to the ingredients. Do not use unless the patient to be treated is, in fact, constipated.

Contraindicated in patients with achlorhydria. Also contraindicated for infants due to the potential risk of spasm of the tongue or respiratory arrest.

Not to use 1 mg tablets in children less then 3 yr of age or when drinking water fluoride content is >= 0.3 ppm.

Acute Overdose

In acute poisoning, symptoms include a salty or soapy taste, increased salivation, GI disturbances, abdominal pain, weakness, drowsiness, faintness and shallow breathing; more serious effects include hypocalcaemia, hypomagnesaemia, hyperkalaemia, tremors, convulsions, cardiac arrhythmias, shock, respiratory arrest and cardiac failure. Death may occur within 2-4 hr. Treatment includes gastric lavage with lime water or a weak solution of another calcium salt to precipitate fluoride. Maintain high urine output, slow IV inj of calcium gluconate 10% may be used for hypocalcaemia and tetany. Magnesium sulfate may be given to treat hypomagnesaemia, and aluminium hydroxide may help to reduce fluoride absorption. Haemodialysis may be considered. Chronic fluoride poisoning may cause skeletal fluorosis resulting in bone pain, stiffness, limited movment and in severe cases, crippling deformities. In children, prolonged excessive intake during tooth development before eruption may cause dental fluorosis characterised by mottled enamel.