Prevantics

Donepezil hydrochloride tablets should be taken in the evening, just prior to retiring.

Donepezil hydrochloride tablets can be taken with or without food.

The dosages of donepezil hydrochloride tablets shown to be effective in controlled clinical trials are 5 mg and 10 mg administered once per day.

The higher dose of 10 mg did not provide a statistically significantly greater clinical benefit than 5 mg. There is a suggestion, however, based upon order of group mean scores and dose trend analyses of data from these clinical trials, that a daily dose of 10 mg of donepezil hydrochloride tablets might provide additional benefit for some patients. Accordingly, whether or not to employ a dose of 10 mg is a matter of prescriber and patient preference.

Donepezil hydrochloride tablets have been shown to be effective in controlled clinical trials at a dose of 10 mg administered once daily.

The recommended starting dose of donepezil hydrochloride tablets is 5 mg once daily. Evidence from the controlled trials in mild to moderate Alzheimer’s disease indicates that the 10 mg dose, with a one week titration, is likely to be associated with a higher incidence of cholinergic adverse events compared to the 5 mg dose. In open-label trials using a 6 week titration, the type and frequency of these same adverse events were similar between the 5 mg and 10 mg dose groups. Therefore, because donepezil hydrochloride tablets steady state is achieved about 15 days after it is started and because the incidence of untoward effects may be influenced by the rate of dose escalation, a dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks.

Treatment should include general supportive care, atropinization, and decontamination, in addition to the use of PROTOPAM Chloride. Treatment is most effective if initiated immediately after poisoning. Administration of PROTOPAM Chloride should be carried out slowly and, preferably, by infusion. If intravenous administration is not feasible, intramuscular or subcutaneous injection should be used. Generally, little is accomplished if PROTOPAM Chloride is given more than 36 hours after termination of exposure to the poison. When the poison has been ingested, it is particularly important to take into account the likelihood of continuing absorption from the lower bowel since this constitutes new exposure and fatal relapses have been reported after initial improvement. In such cases, additional doses of PROTOPAM Chloride may be needed every three to eight hours. In effect, the patient should be “titrated” with PROTOPAM Chloride as long as signs of poisoning recur. As in all cases of organophosphate poisoning, care should be taken to keep the patient under observation for at least 48 to 72 hours.

If dermal exposure has occurred, clothing should be removed and the hair and skin washed thoroughly with sodium bicarbonate or alcohol as soon as possible.

Supportive care, including airway management, respiratory and cardiovascular support, correction of metabolic abnormalities, and seizure control, may be necessary in cases of severe organophosphate poisoning.

Atropine should be given as soon as possible after hypoxemia is improved. Atropine should not be given in the presence of significant hypoxia due to the risk of atropine-induced ventricular fibrillation. In adults, atropine may be given intravenously in doses of 2 to 4 mg. This should be repeated at 5- to 10-minute intervals until full atropinization (secretions are inhibited) or signs of atropine toxicity appear (delirium, hyperthermia, muscle twitching).

Some degree of atropinization should be maintained for at least 48 hours, and until any depressed blood cholinesterase activity is reversed.

Use of morphine, theophylline, aminophylline, reserpine, and phenothiazine-type tranquilizers should be avoided in patients with organophosphate poisoning (see PRECAUTIONS, Drug Interactions). Prolonged paralysis has been reported in patients when succinylcholine is given with drugs having anticholinesterase activity; therefore, it should be used with caution.

After the effects of atropine become apparent, PROTOPAM Chloride may be administered.

PROTOPAM Chloride dosing is based, in part, on the severity of symptoms of nerve agent intoxication. These symptoms include the following:

MILD symptoms:

SEVERE symptoms:

* These symptoms are sometimes observed in healthy infants and young children. In this age group, these symptoms are less reliable than other symptoms listed. Symptoms must be considered collectively when nerve agent or pesticide exposure is known or suspected.

** Infants may become drowsy or unconscious, with muscle floppiness rather than muscle twitching, soon after exposure to nerve agents or pesticides.

Refer to the Preparation for Administration section for instructions on reconstitution and dilution of PROTOPAM Chloride that result in a 10-20 mg/mL solution for intravenous infusion.

Inject an initial dose of 1000 to 2000 mg of PROTOPAM Chloride, preferably as an infusion in 100 mL of normal saline, over a 15- to 30-minute period. If this is not practical or if pulmonary edema is present, the dose should be given slowly (over not less than five minutes) by intravenous injection, as a 50 mg/mL solution in water (e.g., 1000 mg in 20 mL). A second dose of 1000 to 2000 mg may be indicated after about one hour if muscle weakness has not been relieved. Additional doses may be given every 10-12 hours if muscle weakness persists.

Intravenous administration of PROTOPAM Chloride should be carried out slowly and, preferably, by continuous or intermittent infusion, since temporary worsening of cholinergic manifestations (i.e. tachycardia, cardiac arrest, laryngospasm, and muscle rigidity or paralysis) may occur if PROTOPAM Chloride is infused too rapidly. The intermittent infusion rate should not exceed 200 mg/minute. If intravenous administration is not feasible, intramuscular or subcutaneous injection should be used.

Evidence suggests that a loading dose followed by continuous intravenous infusion of PROTOPAM Chloride may maintain therapeutic levels longer than traditional short intermittent infusions therapy (see Pharmacokinetics).

Refer to the Preparation for Administration section for instructions on reconstitution of PROTOPAM Chloride that result in an approximate 300 mg/mL solution for intramuscular administration.

Intramuscular dosing in adults should be based on the severity of clinical symptoms.

MILD SYMPTOMS

SEVERE SYMPTOMS

PERSISTENT SYMPTOMS

Refer to the Preparation for Administration section for instructions on reconstitution and dilution of PROTOPAM Chloride that result in 10-20 mg/mL solution for intravenous infusion.

PROTOPAM Chloride can be given as intermittent intravenous infusions or as a loading dose followed by continuous intravenous infusion, depending upon the patient’s clinical condition. The specific dose given should depend upon the severity of the symptoms.

Administer a loading dose of 20-50 mg/kg (not to exceed 2000 mg/dose) over 15-30 minutes followed by a continuous infusion of 10-20 mg/kg/hour.

Administer an initial intermittent infusion of 20-50 mg/kg (not to exceed 2000 mg/dose) over 15-30 minutes. A second dose of 20-50 mg/kg may be indicated after about one hour if muscle weakness has not been relieved. Repeat dosing is permissible every 10-12 hours as needed.

If it is not practical to administer intermittent or continuous intravenous infusions, or if pulmonary edema is present, the 20-50 mg/kg dose should be given slowly (over not less than five minutes) by intravenous injection as a 50 mg/mL solution in water (see Preparation for Administration section). Additional doses may be given every 10-12 hours if muscle weakness persists.

Refer to the Preparation for Administration section for instructions on reconstitution of PROTOPAM Chloride that result in an approximate 300 mg/mL solution for intramuscular administration.

Intramuscular injections in children should be administered in the anterolateral aspect of the thigh to avoid the nerve, artery and vein, as well as the femur.

Pharmacokinetic modeling using published data from the scientific literature was conducted to derive intramuscular dosing recommendations in the pediatric population. The specific intramuscular dose of PROTOPAM Chloride should depend upon the severity of the symptoms.

MILD SYMPTOMS

SEVERE SYMPTOMS

PERSISTENT SYMPTOMS

Weight in kg

Dose Per Injection†

Total Dose per Three-Injection Course‡

< 40kg

15 mg/kg

45 mg/kg

≥ 40 kg§

Use Adult Dosing Recommendations¶

Use Adult Dosing Recommendations

As an antagonist to such anticholinesterases as neostigmine, pyridostigmine, and ambenonium, which are used in the treatment of myasthenia gravis, PROTOPAM Chloride may be given in a dosage of 1000 to 2000 mg intravenously followed by increments of 250 mg every five minutes.

PROTOPAM Chloride is supplied as 1000 mg single-dose vials for injection.

For INTRAVENOUS infusion: Reconstitute a single PROTOPAM Chloride 1000 mg vial by adding 20 mL of Sterile Water for Injection, USP, which results in a 50 mg/mL concentration.

The solution should further be diluted with Normal Saline for Injection, USP to achieve a concentration of 10 to 20 mg/mL (e.g. 1000 mg in 100 mL or 2000 mg in 100 mL).

For fluid restricted patients or for rapid administration (over at least 5 min), a maximum concentration of 50 mg/mL may be used.

For INTRAMUSCULAR injection: Reconstitute a single PROTOPAM Chloride 1000 mg vial by adding 3.3 mL of Sterile Water for Injection, USP for an approximate concentration of 300 mg/mL.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Discard unused solution after a dose has been withdrawn.

There is currently no dosage information available for this product. We apologize for any inconvenience.

Each pump of the LidoRx 3% bottle in 30mL Airless Pumps (NDC:35781-0300-3) will deliver 0.25 mL of LidoRx 3% enough to cover a 2 x 2 inch area of skin. A single application should not exceed 10 g of LidoRx 3%, containing 300 mg of Lidocaine Hydrochloride USP; This would equal 40 pumps of the 30mL Airless bottle. In a 70 kg adult this dose equals 4.3 mg/kg (1.9 mg/lb) Lidocaine Hydrochloride USP. No more than one 30mL Airless Pump bottle, approximately 30g of LidoRx 3% or 900 mg Lidocaine Hydrochloride USP, should be administered in any one day.
Although the incidence of adverse effects with LidoRx 3% is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children less than ten years who have a normal lean body mass and a normal lean body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark’s rule). For example a child of five years weighing 50 lbs., the dose of lidocaine should not exceed 75-100 mg when calculated according to Clark’s rule. In any case, the maximum amount of Lidocaine Hydrochloride USP administered should not exceed 4.3 mg/kg (2.0 mg/lb) of body weight.

Apply a thin film to the affected area two or three times daily not to exceed 12 pumps in twenty four hours (24Hrs). One pump covers an area of 2 x2 inches. Larger areas will require additional applications. Or use as directed by a physician.