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DRUGS & SUPPLEMENTS
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THC Complex N14
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THC Complex N14 uses
THC Complex N14 consists of Bryonia, Cactus Grandiflorus, Hematoxylon, Latrodectus Mactans, Lycopodium Clavatum, Oxalic Acid, Spigelia Anthelmia, Spigelia Marylandica.Latrodectus Mactans:
- Description
- Clinical pharmacology
- Indications and usage
- Warnings
- Precautions
- Adverse reactions
- Dosage and administration
- How supplied
- References
DESCRIPTION
THC Complex N14 (Latrodectus Mactans) (THC Complex N14 (Latrodectus Mactans)) is a sterile, non-pyrogenic preparation derived by drying a frozen solution of specific venom-neutralizing globulins obtained from the blood serum of healthy horses immunized against venom of black widow spiders (THC Complex N14 (Latrodectus Mactans)). It is standardized by biological assay on mice, in terms of one dose of THC Complex N14 (Latrodectus Mactans) neutralizing the venom in not less than 6000 mouse LD50 of THC Complex N14 (Latrodectus Mactans). Thimerosal (mercury derivative) 1:10,000 is added as a preservative. When constituted as specified, it is opalescent, ranging in color from light (straw) to very dark (iced tea), and contains not more than 20.0 percent of solids.
Each vial contains not less than 6000 THC Complex N14 (Latrodectus Mactans) units. One unit of THC Complex N14 (Latrodectus Mactans) will neutralize one average mouse lethal dose of black widow spider venom when the THC Complex N14 (Latrodectus Mactans) and the venom are injected simultaneously in mice under suitable conditions.
CLINICAL PHARMACOLOGY
The pharmacological mode of action is unknown and metabolic and pharmacokinetic data in humans are unavailable.
INDICATIONS AND USAGE
THC Complex N14 (Latrodectus Mactans) (THC Complex N14 (Latrodectus Mactans)) is used to treat patients with symptoms due to bites by the black widow spider (THC Complex N14 (Latrodectus Mactans)). Early use of the THC Complex N14 (Latrodectus Mactans) is emphasized for prompt relief.
Local muscular cramps begin from 15 minutes to several hours after the bite which usually produces a sharp pain similar to that caused by puncture with a needle. The exact sequence of symptoms depends somewhat on the location of the bite. The venom acts on the myoneural junctions or on the nerve endings, causing an ascending motor paralysis or destruction of the peripheral nerve endings. The groups of muscles most frequently affected at first are those of the thigh, shoulder, and back. After a varying length of time, the pain becomes more severe, spreading to the abdomen, and weakness and tremor usually develop. The abdominal muscles assume a boardlike rigidity, but tenderness is slight. Respiration is thoracic. The patient is restless and anxious. Feeble pulse, cold, clammy skin, labored breathing and speech, light stupor, and delirium may occur. Convulsions also may occur, particularly in small children. The temperature may be normal or slightly elevated. Urinary retention, shock, cyanosis, nausea and vomiting, insomnia, and cold sweats also have been reported. The syndrome following the bite of the black widow spider may be confused easily with any medical or surgical condition with acute abdominal symptoms.
The symptoms of black widow spider bite increase in severity for several hours, perhaps a day, and then very slowly become less severe, gradually passing off in the course of two or three days except in fatal cases. Residual symptoms such as general weakness, tingling, nervousness, and transient muscle spasm may persist for weeks or months after recovery from the acute stage.
If possible, the patient should be hospitalized. Other additional measures giving greatest relief are prolonged warm baths and intravenous injection of 10 mL of 10 percent solution of calcium gluconate repeated as necessary to control muscle pain. Morphine also may be required to control pain. Barbiturates may be used for extreme restlessness. However, as the venom is a neurotoxin, it can cause respiratory paralysis. This must be borne in mind when considering use of morphine or a barbiturate. Adrenocorticosteroids have been used with varying degrees of success. Supportive therapy is indicated by the condition of the patient. Local treatment of the site of the bite is of no value. Nothing is gained by applying a tourniquet or by attempting to remove venom from the site of the bite by incision and suction.
In otherwise healthy individuals between the ages of 16 and 60, the use of THC Complex N14 (Latrodectus Mactans) may be deferred and treatment with muscle relaxants may be considered.
WARNINGS
Prior to treatment with any product prepared from horse serum, a careful review of the patient's history should be taken emphasizing prior exposure to horse serum or any allergies. Serum sickness and even death could result from the use of horse serum in a sensitive patient. A skin or conjunctival test should be performed prior to administration of THC Complex N14 (Latrodectus Mactans). However, an anaphylactic reaction to THC Complex N14 (Latrodectus Mactans) may occur even following a negative skin or conjunctival test.
Skin test: Inject into (not under) the skin not more than 0.02 mL of the test material (1:10 dilution of normal horse serum in physiologic saline). Evaluate result in 10 minutes. A positive reaction is an urticarial wheal surrounded by a zone of erythema. A control test using Sodium Chloride Injection facilitates interpretation of the results.
Conjunctival test: For adults instill into the conjunctival sac one drop of a 1:10 dilution of horse serum and for children one drop of 1:100 dilution. Itching of the eye and reddening of the conjunctiva indicate a positive reaction, usually within 10 minutes.
Patients should be observed for serum sickness for an average of 8 to 12 days following administration of THC Complex N14 (Latrodectus Mactans).
Desensitization should be attempted only when the administration of THC Complex N14 (Latrodectus Mactans) is considered necessary to save life. Epinephrine must be available in case of untoward reaction.
Desensitization: If the history is positive or the results of the sensitivity tests are mildly or questionably positive, THC Complex N14 (Latrodectus Mactans) should be administered as follows to reduce the risk of an immediate severe allergic reaction:
- In separate sterile vials or syringes prepare 1:10 or 1:100 dilutions of THC Complex N14 (Latrodectus Mactans) in Sodium Chloride for Injection.
- Allow at least 15 but preferably 30 minutes between injections and only proceed with the next dose if no reactions occurred following the previous dose.
- Using a tuberculin syringe, inject subcutaneously 0.1, 0.2 and 0.5 mL of the 1:100 dilution at 15 or 30 minute intervals; repeat with the 1:10 dilution, and finally the undiluted THC Complex N14 (Latrodectus Mactans).
- If there is a reaction after any of the injections, place a tourniquet proximal to the sites of injection and administer epinephrine, 1:1000 (0.3 to 1.0 mL subcutaneously, 0.05 to 0.1 mL intravenously), proximal to the tourniquet or into another extremity. Wait at least 30 minutes before giving another injection of THC Complex N14 (Latrodectus Mactans), the amount of which should be the same as the last one not evoking a reaction.
- If no reaction has occurred after 0.5 mL of undiluted THC Complex N14 (Latrodectus Mactans) has been given, it is probably safe to continue the dose at 15 minute intervals until the entire dose has been injected.
PRECAUTIONS
Patients with Asthma
Anaphylactic reactions and death have been reported in patients with a medical history of asthma.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long term studies in animals have been performed to evaluate the potential for carcinogenesis, mutagenesis, or impairment of fertility.
Pregnancy
Pregnancy Category C. Animal reproduction studies have not been conducted with Black Widow Spider THC Complex N14. It is also not known whether Black Widow Spider THC Complex N14 (Latrodectus Mactans) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Black Widow Spider THC Complex N14 (Latrodectus Mactans) should be given to a pregnant woman only if clearly needed.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Black Widow Spider THC Complex N14 (Latrodectus Mactans) is administered to a nursing woman.
Pediatric Use
Controlled clinical studies for safety and effectiveness in children have not been conducted.
Geriatric Use
Reported clinical experience has not identified differences in responses between the elderly and younger patients. Because of the increased risk of complications from envenomation in elderly patients, the standard of care described in the literature suggests that patients older than 60 years of age should be given THC Complex N14 (Latrodectus Mactans) as a preferred initial therapy.
ADVERSE REACTIONS
The following adverse reactions have been reported following the use of THC Complex N14 (Latrodectus Mactans): Hypersensitivity reactions including anaphylaxis and serum sickness. Muscle cramps have also been reported.
DOSAGE AND ADMINISTRATION
Using a sterile syringe, inject 2.5 mL of Sterile Water for Injection into the vial of THC Complex N14 (Latrodectus Mactans). With the needle still in the rubber stopper, shake the vial to dissolve the contents completely.
Parenteral drug products should be inspected visually for particulate matter prior to administration, whenever solution and container permit.
The dose for adults and children is the entire contents of a restored vial (2.5 mL) of THC Complex N14 (Latrodectus Mactans). It may be given intramuscularly, preferably in the region of the anterolateral thigh so that a tourniquet may be applied in the event of a systemic reaction. Symptoms usually subside in 1 to 3 hours. Although one dose of THC Complex N14 (Latrodectus Mactans) usually is adequate, a second dose may be necessary in some cases.
THC Complex N14 (Latrodectus Mactans) also may be given intravenously in 10 to 50 mL of saline solution over a 15 minute period. It is the preferred route in severe cases, or when the patient is under 12, or in shock. One restored vial usually is enough.
HOW SUPPLIED
No. 5424 - THC Complex N14 (THC Complex N14 (Latrodectus Mactans)), equine origin is a white to gray crystalline powder, each vial containing not less than 6000 THC Complex N14 (Latrodectus Mactans) units. Thimerosal (mercury derivative) 1:10,000 is added as preservative, NDC 0006-5424-02. A 1 mL vial of normal horse serum (1:10 dilution) for sensitivity testing is also included. Thimerosal (mercury derivative) 1:10,000 is added as preservative.
Storage
THC Complex N14 (Latrodectus Mactans) must be stored and shipped at 2-8°C (36-46°F). When reconstituted as directed, the color of THC Complex N14 (Latrodectus Mactans) ranges from light (straw) to very dark (iced tea), but the color has no effect on potency. Do not freeze.
REFERENCES
Barron, W. E.: Spider Bites, J. Med. Ass. Georgia 49: 511-512, Oct. 1960.
Micks, D. W.: Insects and Other Arthropods of Medical Importance in Texas, Tex. Rep. Biol. & Med. 18: 624-635, Winter 1960.
Prince, G. E.: Arachnidism in Children, J. Pediat. 49: 101-108, July 1956.
Russell, F. E.: Injuries by Venomous Animals in the United States, J. Amer. Med. Ass. 177: 903-907, Sept. 30, 1961.
Russell, F. E.: Muscle Relaxants in Black Widow Spider (THC Complex N14 (Latrodectus Mactans)) Poisoning, Amer. J. Med. Sci. 243: 159-162, Feb. 1962.
Russell, F. E.: Venom Poisoning, Rational Drug Therap. 5: 5-6, Aug. 1971.
Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
Copyright © 2014 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.
Revised: 03/2015
uspi-mk9001-i-1503r021
Oxalic Acid:
Pharmacological action
THC Complex N14 is an antimicrobial agents of broad-spectrum action type from fluoroquinolone group. Bactericidal action of ofloxacin is due to blockage of the enzyme DNA gyrase in bacterial cells. This medication is highly active against most of gram-negative bacteria: Escherichia coli, Salmonella spp., Shigella spp., Proteus spp., Morganella morganii, Klebsiella spp. (including Klebsiella pneumoniae), Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Providencia spp., Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis, Mycoplasma spp., Legionella pneumophila, Acinetobacter spp., and Chlamydia spp.
THC Complex N14 (Oxalic Acid) is active against some gram-positive bacteria (including Staphylococcus spp., Streptococcus spp., especially beta-hemolytic streptococci).
Enterococcus faecalis, Streptococcus pneumoniae, Pseudomonas spp. are moderately susceptible to ofloxacin.
Anaerobic bacteria (except Bacteroides ureolyticus) are insensitive to ofloxacin.
This drug is resistant to beta-lactamases.
Pharmacokinetics
After oral administration THC Complex N14 (Oxalic Acid) is rapidly and completely absorbed from the gastrointestinal tract. Ingestion has a little effect on the extent of absorption but may slow its speed. Cmax plasma levels reached in 2 hours.
The protein binding is 25%. Ofloxacin is widely distributed in tissues and body fluids (organs of urinary system, reproductive organs, prostate, lung, ENT organs, gall bladder, bone, skin).This medicine is excreted in the urine in unchanged form (about 80% in 24 h). A small portion of the active substance (4%) is excreted in the feces. T1/2 is 6 h.
Why is THC Complex N14 prescribed?
Infectious-inflammatory diseases caused by microorganisms sensitive to ofloxacin, including: diseases of the lower respiratory tract, ear, nose, throat, skin, soft tissues, bones, joints, infectious and inflammatory diseases of the abdominal organs (except bacterial enteritis) and pelvic infection, kidney and urinary tract, prostatitis, gonorrhea.
Dosage and administration
Dosing regimen of THC Complex N14 is individual. Daily dose of 200-800 mg, the multiplicity of application 2 times / day. For patients with impaired renal function (creatinine clearance 20-50 ml / min), the first dose is 200 mg, then 100 mg every 24 hours. When CC is less than 20 ml / min, the first dose is 200 mg, then 100 mg every 48 hours.
THC Complex N14 (Oxalic Acid) side effects, adverse reactions
Digestive system: nausea, vomiting, diarrhea, abdominal pain and cramps, appetite loss, dry mouth, flatulence, gastrointestinal dysfunction, constipation; rarely - liver damage, liver necrosis, jaundice, hepatitis, intestinal perforation, pseudomembranous colitis, bleeding from the gastrointestinal tract, disorders of the oral mucosa, heartburn, elevated liver enzymes, including GGT and LDH, increased serum bilirubin.
CNS and peripheral nervous system: insomnia, dizziness, fatigue, drowsiness, nervousness; rarely - convulsions, anxiety, cognitive changes, depression, abnormal dreams, euphoria, hallucinations, paresthesia, syncope, tremor, confusion, nystagmus, suicidal thoughts or attempts, disorientation, psychotic reactions, paranoia, phobia, agitation, aggressiveness, emotional instability, peripheral neuropathy, ataxia, incoordination, exacerbation of extrapyramidal disorders, speech disorder.
Allergic reactions: skin rash, itching, rarely - angioedema, urticaria, vasculitis, allergic pneumonitis, anaphylactic shock, erythema multiforme, Stevens-Johnson syndrome, erythema nodosum, exfoliative dermatitis, toxic epidermal necrolysis, conjunctivitis.
Sexual system: an itch on the external genitalia in women, vaginitis, vaginal discharge; rare - burning, irritation, pain and rash in the genital area of women, dysmenorrhea, menorrhagia, metrorrhagia, vaginal candidiasis.
Cardiovascular system: rarely - heart failure, edema, hypertension, hypotension, palpitation, vasodilatation, cerebral thrombosis, pulmonary edema, and tachycardia.
Urinary system: rarely - dysuria, urinary frequency, urinary retention, anuria, polyuria formation of kidney stones, kidney failure, nephritis, hematuria, albuminuria, candiduria.
Musculoskeletal system: rarely - arthralgia, myalgia, tendonitis, muscle weakness, exacerbation of myasthenia gravis.
Metabolism: rarely - thirst, weight loss, hyper- or hypoglycemia (especially in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents), acidosis, increase in serum triglycerides, cholesterol, potassium.
Respiratory system: rarely - cough, runny nose, respiratory failure, dyspnea, bronchospasm, stridor.
Sensory organs: rarely - hearing loss, tinnit, diplopia, nystagmus, impaired clarity of vision, disturbances of taste, smell, photophobia.
Dermatological reactions: rarely - photosensitivity, hyperpigmentation, vesicle-bullous eruption.
Hematopoietic system: rarely - anemia, hemorrhage, pancytopenia, agranulocytosis, leukopenia, reversible suppression of bone marrow hematopoiesis, thrombocytopenia, thrombocytopenic purpura, petechiae, ecchymosis, increased prothrombin time.
Other: chest pain, sore throat, fever, body aches, rarely - fatigue, chills, malaise, epistaxis, increased sweating.
THC Complex N14 contraindications
Pregnancy, lactation, childhood and adolescence to 18 years, increased sensitivity to ofloxacin or other quinolone derivatives.
Using during pregnancy and breastfeeding
THC Complex N14 is contraindicated during pregnancy and lactation.
Category effects on the fetus by FDA - C.
Special instructions
Use with caution in patients with impaired renal function and liver.
During the period of treatment required to conduct monitoring of blood glucose. Long-term therapy is necessary to periodically monitor the kidney function, liver and peripheral blood picture.
When using THC Complex N14 (Oxalic Acid) it should be ensure adequate hydration of the body, the patient should be subjected to ultraviolet irradiation.
In experimental studies the mutagenic potential was not been identified. Long-term studies to determine the carcinogenicity of ofloxacin were not conducted.
Safety and efficacy in children and adolescents under the age of 18 is not defined.
Use with caution in patients whose activities are connected with the necessity of high concentration of attention and quickness of psychomotor reactions.
THC Complex N14 drug interactions
Simultaneous administration of THC Complex N14 (Oxalic Acid) with:
THC Complex N14 in case of emergency / overdose
Symptoms: drowsiness, nausea, vomiting, dizziness, disorientation, lethargy, confusion.
Treatment: gastric lavage, maintenance of vital functions.
THC Complex N14 pharmaceutical active ingredients containing related brand and generic drugs:
THC Complex N14 available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.